CP Tracker

FDA Citizen Petition Tracker
Docket No. Petitioner Product Name/Issue Category
FDA-2017-P-1108 Orbicular TIMOPTIC (Timolol Maleate) Drug

Pharmaceutical Ophthalmic Solution, 0.25%
Technologies and 0.5%
FDA-2017-P-1104 Gator Pharmaceuticals, Colon Preparation Kits Drug
Inc. (COLPREP Kit)
FDA-2017-P-1096 Hyman, Phelps & VASOSTRICT (vasopressin) Drug

McNamara, P.C. Injection, 20 units per mL
FDA-2017-P-1039 Beck & Thomas Potassium Chloride Oral Drug Drug

Products
FDA-2017-P-1002 Inrange Systems, Inc. Product Detention Medical

Device
FDA-2017-P-0970 RiceBran Technologies Rice Bran/Rice Fiber Food
FDA-2017-P-0868 David Wong Quetiapine Fumerate Drug

Extended-Release Tablets 180-
Day Exclusivity
FDA-2017-P-0867 Public Citizen HES IV Solutions Drug
FDA-2017-P-0866 Hyman Phelps & THIOPLEX (thiotepa) for Drug

McNamara, P.C. Injection, 15 mg/vial
FDA-2017-P-0864 Hyman Phelps & Ibuprofen Tablets, 200 mg Drug

McNamara, P.C.
FDA-2017-P-0863 Fresenius Kabi USA, Sodium Chloride 23.4% Drug

LLC Injection USP, 100 mL and 200
mL
FDA-2017-P-0840 The Weinberg Group OVRETTE (norgestrel) Tablets Drug
FDA-2017-P-0757 Vertice Pharma, Inc. Potassium Chloride Oral Drug Drug

Products
FDA-2017-P-0663 Mucodel Pharma, LLC Intranasal Naloxone Drug
FDA-2017-P-0662 Impax Laboratories, Inc. RYTARY (carbidopa and Drug

levodopa) Extended-release
Capsules
FDA-2017-P-0508 Union of Concerned Added Sugars Food
Scientists, Center for
Science and
Democracy
FDA-2017-P-0495 Lachman Consultant CORDARONE (amiodarone Drug

Services, Inc. HCl) Tablets, 200mg
FDA-2017-P-0494 Navinta LLC Sodium Phenylacetate and Drug

Sodium Benzoate injection,
10%/10%, 20 ml fill volume
FDA-2017-P-0428 Mucodel Pharma LLC Intranasal Naloxone Drug
FDA-2017-P-0398 Florek & Endres PLLC Hydromorphone HCl Extended- Drug

release Tablets, 24 mg
FDA-2017-P-0290 Malaysian Rubber Powdered Gloves Medical

Export Promotion Device
Council
FDA-2017-P-0176 American Herbal Sperm Donation Industry Dietary
Products Association Supplement
FDA-2017-P-0137 Macleods Pyrazinamide Tablets 500 mg Drug

Pharmaceuticals
Limited
FDA-2017-P-0115 Jubilant Generics Levetiracetam Injection, Drug
Limited 1000mg/10 ml and 1500 mg/15
ml
FDA-2017-P-0052 Donor Sibling Registry Sperm Donation Industry Misc
Petition Tracker
LAST UPDATED: 2/27/2017
Petition Type Receipt Date Decision Date Decision
Citizen Petition - 2/22/2017 Pending

Listed Drug
Discontinuation
Citizen Petition 2/21/2017 Pending

Listed Drug
Discontinuation
(505(q) Certification)

Listed Drug
Discontinuation
Citizen Petition - RLD 2/8/2017 Pending
Designation

ANDA Suitability
Petition
Listed Drug
Discontinuation
Citizen Petition 2/3/2017 2/10/2017 Withdrawn


Listed Drug
Discontinuation
ANDA Suitability
Petition

ANDA Suitability
Petition

Designation

ANDA Suitability
Petition
FDA-2016-P-4587 Mallinckrodt INOmax (nitric oxide) Drug

Pharmaceuticals
FDA-2016-P-4585 Acorda Therapeutics, AMPYRA (dalfampridine) Drug

Inc. Extended-release Tablets
FDA-2016-P-4584 Public Citizen Health Repaglinide-containing Drug

Research Group Medications (PRANDIN,
PRANDIMET)
FDA-2016-P-4388 Dr. S. Varghese Loperamide (Imodium) - OTC- Drug
to-Rx Switch
FDA-2016-P-4341 Osmotica Venlafaxine HCl Extended- Drug

Pharmaceutical US LLC release Tablets, 225 mg
FDA-2016-P-4275 BioNeutra North Dietary Fibers - Isomalto- Food

America Inc. oligosaccharides
FDA-2016-P-4274 Teligent, Inc. Mupirocin Ointment 2% Drug
FDA-2016-P-4233 KFSU Ltd. Sugarcane Flour Food
FDA-2016-P-4186 Lachman Consultant CALCIMAR (calcitonin salmon) Drug

Services, Inc. Injection, 200 IU/mL
FDA-2016-P-4164 Lachman Consultant Carbinoxamine Maleate Orally Drug

Services, Inc. Disintegrating Tablets, 2 mg, 4
mg, 6 mg and 8 mg
FDA-2016-P-4141 Upsher-Smith QUDEXY XR (topiramate) Drug
Laboratories, Inc. Extended-release Capsules
(TE Rating)
FDA-2016-P-4095 Mapi USA, Inc. Carglumic Acid Tablets, 50 mg Drug
(Medunik Canada Ltd.) and 200 mg
FDA-2016-P-4094 Adapt Pharma Intranasal Naloxone Drug

Operations Ltd.
FDA-2016-P-4093 Ferring Desmopressin to Treat Drug
Pharmaceuticals Inc. Nocturia
FDA-2016-P-4047 Mayne Pharma DORYX MPC (doxycycline Drug

lnternational Pty Ltd. hyclate) Delayed-release
Tablets
FDA-2016-P-3968 International Probiotics Dietary Supplement Labeling Food
Association
FDA-2016-P-3912 Adapt Pharma NARCAN (naloxone) Nasal Drug

Operations Ltd Spray
FDA-2016-P-3823 Jennifer A. Osler TBD TBD
FDA-2016-P-3753 MacLeods Diclofenac Sodium Topical Drug

Pharmaceuticals Solution, 1.5%
Limited
FDA-2016-P-3696 ANDA Consultants FML (fluorometholone Drug
ophthalmic Suspension)
FDA-2016-P-3674 Consumers for Dental Dental Amalgum Drug

Choice
FDA-2016-P-3620 MGP Ingredients, Inc. Modified Wheat Starch Food

(Fibersym® RW and
FiberRite® RW)
FDA-2016-P-3598 Axinn, Veltrop & EVOLMELA (melphalan HCl) Drug
Harkrider LLP for Injection, Eq. 50 mg
base/vial
FDA-2016-P-3560 Orchid Healthcare CEDAX (Ceftibuten for Oral Drug
Suspension)
FDA-2016-P-3510 Zhuhai Kinhoo Cefadroxil Chewable Tablets Drug

Pharmaceutical Co., 125 mg and 250 mg
Ltd.
FDA-2016-P-3509 Metabolic Therapy Inc. OTC External Analgesics - Drug
Melatonin and Inositol
hexaphosphate
FDA-2016-P-3482 Zydus Pharmaceuticals LYNPARZA (olaparib) Drug
(USA) Inc Capsules, 50 mg
FDA-2016-P-3465 Novitium Pharma LLC Ranitidine Capsules, 150 mg Drug

and 300 mg
FDA-2016-P-3463 Axinn, Veltrop & Apixaban Tablets, 10 mg Drug

Harkrider LLP
FDA-2016-P-3428 Felix Pharmaceuticals Cefpodoxime Proxetil Animal Drug

Pvt. Ltd. Chewable Tablets
FDA-2016-P-3427 Felix Pharmaceuticals Carprofen Chewable Tablets Animal Drug
Pvt. Ltd.
FDA-2016-P-3426 Novitium Pharma LLC Minipress Capsules, EQ 2mg Drug

base
FDA-2016-P-3418 Salix Pharmaceuticals, XIFAXAN (rifaximin) Tablets Drug

Inc.
FDA-2016-P-3356 Sandoz Inc. ADVAIR DISKUS100/50 Drug

(fluticasone propionate 100
mcg and salmeterol 50 mcg
inhalation powder)
FDA-2016-P-3313 Purdue Pharma L.P. BUTRANS (buprenorphine) Drug

Transdermal System
FDA-2016-P-3312 Gilead Sciences, Inc. STRIBILD (elvitegravir, Drug

cobicistat, emtricitabine,
tenofovir disoproxil fumarate)
Tablets
FDA-2016-P-3311 Tate & Lyle Ingredients Polydextrose Food

Americas LLC/DuPont
Nutrition & Health
FDA-2016-P-3195 Wood, Herron & Evans, MagnaTouch MRI Music Medical
LLP System, Genesis Ultra MRI Device
Music System, MagnAlarm
FDA-2016-P-3162 ANDA Consultants Terbutaline Sulfate Tablets, 5 Drug
mg
FDA-2016-P-3112 Mario Morais Citizen Petition Response Misc

Timeframes
FDA-2016-P-3089 Aleon Pharma Cefixime Tablet for Oral Drug

International, Inc. Suspension 50mg, 100mg, and
200mg
FDA-2016-P-3082 Pfizer Inc. DUAVEE (conjugated Drug
estrogens/bazedoxifene)
FDA-2016-P-3070 DuPont Nutrition & Soy Fiber Food

Health
FDA-2016-P-3052 Lehigh Valley Unapproved Drugs - Drug

Technologies, Inc. Enforcement Action
FDA-2016-P-3015 Felix Pharmaceuticals Enrofloxacin Taste Tab Animal Drug

Pvt. Ltd. Antibacterial Tablet
FDA-2016-P-2955 Nicholas Isel Sperm and/or Egg Donation Biologics

Assisted Reproductive
Technology
FDA-2016-P-2860 General Mills, Inc Dietary Fiber Food
FDA-2016-P-2782 Alcon Pharmaceuticals, CIPRODEX (ciprofloxacin 0.3% Drug

Ltd. and dexamethasone 0.1%)
Otic Suspension
FDA-2016-P-2781 Alcon Pharmaceuticals, DUREZOL (difluprednate Drug
Ltd. ophthalmic emulsion) 0.05%
FDA-2016-P-2738 Metabolic Therapy Inc. OTC Acne Drug Products Drug

Monograph (Chromium)
FDA-2016-P-2737 Natural Resources Antibiotics in Livestock and Animal Drug

Defense Council Poultry
FDA-2016-P-2736 Beneo, Cosucra Inulin-type Fructans Derived Food

Groupe Warcoing S.A., from Chicory Root as
and Sensus B.V. Dietary Fiber
FDA-2016-P-2713 Strides Pharma Inc. Amantadine Hydrochloride, Drug
Capsule, 100 mg
FDA-2016-P-2676 Joshua Schroeder Misbranded Major Food Food

Allergens and Adulterated
Foods
FDA-2016-P-2675 Foley & Lardner LLP GYNOREST (dydrogesterone) Drug
Tablets
FDA-2016-P-2674 Heritage Pharma, Inc. CALAN SR (Verapamil HCl) Drug

Sustained-release Tablets, 180
mg
FDA-2016-P-2672 Jazz Pharmaceuticals XYREM (sodium oxybate) Drug
Inc.
FDA-2016-P-2654 Vanda Fanapt (Iloperidone) Tablets Drug

Pharmaceuticals, Inc.
FDA-2016-P-2568 Fresenius Kabi USA Sodium Chloride in Plastic Drug

Container (2.5 mEq/mL)
FDA-2016-P-2559 Emord and Associates, Electroconvulsive Therapy Medical

P.C. Devices Device
FDA-2016-P-2558 Similasan Corporation Homeopathic Pink Eye Drug

Remedies for OTC Use
FDA-2016-P-2533 American Feed Industry Electronic Records - Veterinary Animal Drug

Association and Feed Directives
National Grain and
Feed Association
FDA-2016-P-2532 David K. Cundiff Vitamin K2 Intakes Food

FDA-2016-P-2515 Eli Lilly and Company FORTEO (teriparatide [rDNA Drug
origin] injection)
FDA-2016-P-2497 Clinical Decision Digital Health Pharmaceutical Drug/Device

Support Coalition Products
FDA-2016-P-2478 United Therapeutics TYVASO (treprostinil) Drug

Corporation Inhalation Solution
FDA-2016-P-2469 Hyman, Phelps & SYMMETREL (amantadine Drug

McNamara, P.C. hydrochloride) Syrup, 50 mg/5
mL
FDA-2016-P-2467 Actavis LLC Azacitidine for Injection, 100 Drug
mg/vial
FDA-2016-P-2377 Archer Daniels Midland Fibersol resistant maltodextrin Food

Company as Dietary fiber
FDA-2016-P-2376 Par Sterile Products, ADRENALIN (epinephrine Drug

LLC injection) 1 mg/mL, 1 mL vial
FDA-2016-P-2375 AKORN Specialty Furosemide Injection, 10 Drug

Generics mg/mL
FDA-2016-P-2344 ANDA Consultants Furosemide Injection, 10 Drug

mg/mL
FDA-2016-P-2342 Sovereign Metaxalone Tablets, 400 mg Drug

Pharmaceuticals, LLC and 640 mg
FDA-2016-P-2337 Lachman Consultant Leucovorin Calcium Injection Drug

Services, Inc. USP, 50 mg/5 mL, 100 mg/10
mL, 200 mg/20 mL, and 350
mg/35 mL
FDA-2016-P-2091 ANDA Consultants Furosemide Injection, 10 Drug

mg/mL
FDA-2016-P-2072 Pacific-Link Consulting Naloxone Containing Product Drug

(Adapt Pharma)
FDA-2016-P-2030 The Food Lawyers Allulose Food
FDA-2016-P-2029 Virtus Pharmaceuticals PDUFA User Fees Drug

OpCo, LLC
FDA-2016-P-1991 Felix Pharmaceuticals Carprofen Chewable Tablets Animal Drug

Pvt. Ltd
FDA-2016-P-1962 Allergan plc LINZESS (linaclolide) Capsules Drug

FDA-2016-P-1955 Mallinckrodt INOmax DSIR Plus Drug/Device
Pharmaceuticals
FDA-2016-P-1952 Fresenius Kabi USA, ROBINUOL (glycopyrrolate Drug

LLC injection)
FDA-2016-P-1946 Collegium Oxycodone ER Abuse- Drug

Pharmaceutical, Inc. Deterrent Drugs
FDA-2016-P-1875 Pacific-Link Consulting Prescription Dopamine Agonist Drug

(Adapt Pharma) Drugs
FDA-2016-P-1874 Public Citizen Health Prescription Dopamine Agonist Drug

Research Group Drugs
FDA-2016-P-1873 Teva Pharmaceuticals AMRIX (cyclobenzaprine HCl) Drug

Extended-release Capsules, 15
and 30 mg
FDA-2016-P-1852 Farm-To-Consumer Interstate Sales of Food
Legal Defense Fund Unpasteurized Butter
FDA-2016-P-1826 NuTek Food Science Potassium Salt Food

LLC
FDA-2016-P-1825 Lachman Consultant KENALOG-40 (triamcinolone Drug

Services, Inc. acetonide)
Injectable Suspension
FDA-2016-P-1725 Lachman Consultant Flonase (fluticasone Drug
Services, Inc. propionate) Nasal Spray, 0.05
mg
FDA-2016-P-1676 JR Rapoza Associates, Cyanocobalamin Injection 1000 Drug
Inc. mcg/mL in a 10 ml vial
FDA-2016-P-1674 Tate & Lyle Ingredients Soluble Corn Fiber Food

Americas LLC
FDA-2016-P-1667 Zydus Pharmaceutical ANTIVERT (Meclizine Drug

(USA) Inc Hydrochloride) Tablets, 12.5
mg and 25 mg
FDA-2016-P-1650 Lannett Company, Inc. Morphine Sulfate Oral Solution, Drug
100 mg/5 mL
FDA-2016-P-1547 Baxter Healthcare Levofloxacin Injection in 5% Drug

Corporation Dextrose
FDA-2016-P-1485 AstraZeneca CRESTOR (rosuvastatin Drug

Pharmaceuticals LP calcium)
FDA-2016-P-1398 Dr. Hooman Clearance of the Pneumoliner Medical

Noorchashm Containment System for use Device
with Power Morcellators
FDA-2016-P-1364 Lachman Consultant Paclitaxel for Injection Drug
Services, Inc. Suspension, in a 250 mg/vial
lyophilized powder
FDA-2016-P-1363 Gordon Johnston Sodium Chloride Injection Drug
Regulatory Consultants, 23.4%
LLC
FDA-2016-P-1319 Florek & Endres PLLC Daptomycin Powder for Drug
Intravenous Use, 350 mg/vial
FDA-2016-P-1314 Center for Responsible Skin and Eye Irritation Testing Drug
Science Methods
FDA-2016-P-1303 Consumers for Dental Dental Amalgum Drug

Choice
FDA-2016-P-1288 Fluoride Action Network Sodium Fluoride-containing Drug

Drops, Tablets, and Lozenges
FDA-2016-P-1287 Lachman Consultant Amphotericin B Liposome for Drug

Services, Inc. Injection, 250 mg/vial
lyophilized powder
FDA-2016-P-1286 Lachman Consultant Glycopyrrolate Injection, 0.1 Drug
Services, Inc. mg/0.5 mL
FDA-2016-P-1285 Mylan Pharmaceuticals Furosemide Injection, USP-10 Drug

Inc. mg/mL in 2 mL, 4 mL & 10 mL
fill
FDA-2016-P-1251 Lachman Consultant Busulfan Injection, 30 mg/5 mL Drug
Services, Inc.
FDA-2016-P-1250 PTS Consulting Chlorpromazine Hydrochloride Drug

Tablets, 100 mg
FDA-2016-P-1249 Haner & Kuo, PLLC Potassium Chloride Oral Drug

Solution
FDA-2016-P-1247 ABHAI, LLC METADATE ER Drug

(methylphenidate HCl)
Extended-release Tablets
FDA-2016-P-1246 Working Group on Low-dose Vaginal Estrogen Drug
Women's Health and Product Labeling
Well-Being in
FDA-2016-P-1213 Menopause and The
Medtech Products Inc. Acetaminophen 250 mg, Drug
North American Aspirin 250 mg, and Caffeine
Menopause Society 65 mg Powder
FDA-2016-P-1212 Medtech Products Inc. Acetaminophen 250 mg, Drug
Aspirin 250 mg, and Caffeine
65 mg Powder for Solution
FDA-2016-P-1211 Medtech Products Inc. Acetaminophen 250 mg, Drug
Aspirin 250 mg, and Caffeine
65 mg Chewable Tablets
FDA-2016-P-1180 Top Health Ingredients Isomaltooligosaccaride; List of Food
Inc. Dietary Fibers
FDA-2016-P-1171 Breast Cancer Fund et Ortho-phthalates Drug

al.
FDA-2016-P-1169 e5 Pharma LLC Methimazole Rapidly Drug

Disintegrating
Tablets
FDA-2016-P-1163 Vifor Fresenius Medical VELPHORO (sucroferric Drug

Care Renal Pharma oxyhydroxide)
France
FDA-2016-P-1158 Amanda Williams Food Allergen Information on Food
the Bulk Candy Packaging
FDA-2016-P-1133 ProbioTech LLC Probiotic Suppositories Dietary

Supplement
FDA-2016-P-1128 Melissa Schilling Glycemic Load of Packaged Food

Food
FDA-2016-P-1115 Mostyn Law Firm Class I recall of Products made Medical

with Counterfeit, Chinese Device
Resin
FDA-2016-P-1108 Gordon Johnston Dextrose 5% and Sodium Drug
Regulatory Consultants, Chloride Injection 0.9%
LLC Injection in Plastic Container
FDA-2016-P-1104 Gordon Johnston Dextrose 2.5% and Sodium Drug
FDA-2016-P-1090 Lachman Consultant Naloxone and Opioid Abuse Drug
Services, Inc.
FDA-2016-P-1088 ABHAI LLC Oxybutynin Chloride Drug

Tablets, 2.5 mg
FDA-2016-P-1085 Frontage Laboratories, Acetylcysteine Injection, Drug

Inc. 2GM/10ML and 4GM/20ML
FDA-2016-P-1073 PAR Pharmaceutical Potassium Chloride Oral Drug
Solution
FDA-2016-P-1037 Emprise Pharma Prevacid IV 30 mg/vial Drug
FDA-2016-P-1027 Gland Pharma Limited BENDEKA (Bendamustine HCl Drug

Solution for IV infusion,
100mg/4 mL) Injection
FDA-2016-P-1026 Germaine Laboratories, Aim Tab Reducing Substances/ Medical
Inc. 510(k) Requirements Device
FDA-2016-P-0974 Gordon Johnston SAMSCA (Tolvaptan) Tablets, Drug

Regulatory Consultants, 60 mg
LLC
FDA-2016-P-0770 International Isotopes Xenon XE 133 Gas; Inhalation Drug
Inc. 20mCi/Vial
FDA-2016-P-0769 Empire State Consumer Selenium in PEG 3350 Drugs Drug

Project, Inc.
FDA-2016-A-0746 James T. O'Reilly, Food Grade Salt Derived from Food

University of Cincinnati Radioactive Liquid Waste
FDA-2016-P-0713 Pernix Therapeutics ZOHYDRO ER (hydrocodone Drug

bitartrate) Extended-release
Capsules
FDA-2016-P-0689 Baltimore City Benzodiazepine Black Box Drug
Department of Health, Warning
et al.
FDA-2016-P-0656 Steven Zecola Precision Medicine Initiative Drug
FDA-2016-P-0645 Pharmaceutical Abuse-Deterrent Drugs Drug

Manufacturing
Research Services
FDA-2016-P-0644 Gordon Johnston Olmesartan Medoxomil Tablets, Drug
Regulatory Consultants, 10 mg
LLC
FDA-2016-P-0621 Helsinn Healthcare SA ALOXI (palonosetron HCl) Drug
Injection
FDA-2016-P-0618 Emily Connor Definition of "Spices" on Food Food

Labels
FDA-2016-P-0542 Gordon Johnston Calcium Chloride; Potassium Drug

Regulatory Consultants, Chloride; Sodium Chloride;
LLC Sodium Injection,
20mg/100mL; 30mg/100mL;
600mg/100mL; 310mg/100mL
in Plastic Containers
FDA-2016-P-0541 Gordon Johnston Sodium Chloride Injection Drug
Regulatory Consultants, 0.45% in Plastic Container
LLC
FDA-2016-P-0540 Gordon Johnston Sodium Chloride Injection 3% Drug
Regulatory Consultants, in Plastic Container
LLC
FDA-2016-P-0383 Depomed Inc. NUCYNTA ER (tapentadol) Drug
FDA-2016-P-0378 The Weinberg Group, TRIVARIS (triamcinolone Drug

Inc. acetonide)
FDA-2016-P-0214 Rosalind Advisors, Inc. Extracorporeal Liver Assist Drug

Device Clnical Hold
FDA-2016-P-0187 United Therapeutics TYVASO (treprostinil) Drug

Corporation
FDA-2016-P-0159 Biorex Labs LLC 510(k) Exemption Medical

Device
FDA-2016-P-0147 Bumble Bee Foods, Canned Tuna Food

LLC
FDA-2016-P-0135 Hyman, Phelps & Permethrin Cream, 5% Drug

McNamara, P.C.
FDA-2016-P-0134 Summit Phenylbutazone Powder Animal Drug

FDA-2016-P-0040 Troutman Sanders LLP AMICAR (aminocaproic acid) Drug

Tablets, 1000 mg
FDA-2016-P-0031 Indoco Remedies Furosemide Injection, 10 Drug

Limited mg/mL
Petition Tracker

Citizen Petition 12/28/2016 1/23/2017 Granted in Part;

(505(q) Certification) Denied in Part


Designation

Listed Drug
Discontinuation
ANDA Suitability
Petition

ANDA Suitability
Petition


Designation

Designation

Listed Drug
Discontinuation
ANDA Suitability
Petition
Citizen Petition - RLD 10/18/2016 2/22/2017 Withdrawn

Designation

Designation

ANDA Suitability
Petition
Citizen Petition - 10/172016 Pending
ANADA Suitability
Petition
Citizen Petition - 10/17/2016 1/12/2017 Granted
ANADA Suitability
Petition
Designation





Designation
Citizen Petition 9/15/2016 1/19/2017 Denied

ANDA Suitability
Petition

ANADA Suitability
Petition



Designation

Listed Drug
Discontinuation
Citizen Petition - 8/31/2016 11/8/2016 Not Discontinued for
Listed Drug S/E Reasons
Discontinuation
Citizen Petition 9/9/2016 1/17/2017 Granted


Designation
Citizen Petition 8/25/2016 2/2/2017 Interim Response



Discontinuation

Citizen Petition - RLD 7/27/2016 1/26/2017 Interim Response

Designation

Listed Drug
Discontinuation
ANDA Suitability
Petition
ANDA Suitability
Petition

Discontinuation

ANADA Suitability
Petition

Discontinuation

Citizen Petition - 6/24/2016 12/15/2016 Interim Response

Listed Drug
Discontinuation
Listed Drug
Discontinuation
Listed Drug
Discontinuation

Listed Drug
Discontinuation
Citizen Petition - RLD 6/8/2016 12/2/2016 Granted

Designation


ANDA Suitability
Petition
Discontinuation
ANDA Suitability
Petition

ANDA Suitability
Petition
ANDA Suitability
Petition
ANDA Suitability
Petition
ANDA Suitability
Petition
Designation


ANDA Suitability
Petition
ANDA Suitability
Petition
ANDA Suitability
Petition
Citizen Petition - 4/13/2016 6/10/2016 Denied

ANDA Suitability
Petition
Petition for 7/8/2016 Pending
Reconsideration


Designation

Designation

Designation

Designation

Designation

ANDA Suitability
Petition
ANDA Suitability
Petition

Discontinuation
Designation

Discontinuation
Designation

(Advisory Opinion)


Denied in Part

ANDA Suitability
Petition

Designation
Designation

Designation

Citizen Petition 1/28/2016 6/2/2016 Not Discontinued for

(505(q) Certification) S/E Reasons

Listed Drug
Discontinuation

Designation

ANADA Suitability
Petition

Listed Drug
Discontinuation &
RLD Designation

Designation
FDA-2015-A-5109 Wallace, Jordan, Ratliff Effect of FDA import Alerts on Drug

& Brandt, LLC Private Party Contracts
FDA-2015-P-5108 Purdue Pharma L.P. Extended-release Oxycodone Drug
FDA-2015-P-5081 O'Hara, et al. Gluten Content in Medications Drug
FDA-2015-P-5022 PhRMA & BIO Biosimilar Labeling Biologic
FDA-2015-P-4959 Cardinal Health Trientine HCl Capsules, 500 Drug

Regulatory Sciences mg
FDA-2015-P-4946 Zydus Pharmaceuticals ZAROXOLYN (metolazone) Drug

(USA) Inc. Tablets, 5 mg and 10 mg
FDA-2015-P-4945 Ryszard Rokicki Essure Medical

Device
FDA-2015-P-4935 AbbVie Inc. Biosimilar Interchangeability Biologic
FDA-2015-P-4916 REGCON Solutions Ipratropium Bromide; Albuterol Drug

Sulfate Inhalation Solution,
0.083% Base/0.017%
FDA-2015-A-4705 Consorzio del Food Ingredients Listing Food
Formaggio Parmigiano-
Reggiano
FDA-2015-P-4664 Richard Fife Live Turtles & Viable Turtle Other
Eggs
FDA-2015-P-4601 Frier Levitt Compounded Implantable Drug

Testosterone Pellets
FDA-2015-P-4600 Bayer HealthCare LLC MIRENA (Levonorgestrel- Drug

releasing intrauterine system)
FDA-2015-P-4529 UAW Retiree Medical Biosimilar Labeling Drug
Benefits Trust
FDA-2015-P-4582 Margaret Moustafa Safety Information on Statins & Drug

Pulmonary Fibrosis
FDA-2015-P-4566 Concordia LANOXIN (Digoxin) Tablets Drug

Pharmaceuticals
FDA-2015-P-4564 KIND LLC Food Labeling & Dietary Food

Guidelines for Americans
FDA-2015-P-4307 Guy Aliotta Warnings for Xylitol or Other Food

Sugar Alcohols
FDA-2015-P-4237 Gland Pharma Limited Mesna Injection, 20mg/mL (50 Drug

mL IV infusion bag)
FDA-2015-P-4231 REGCON Solutions Phenylephrine HCl Ophthalmic Drug

Solution/Drops 2.5% & 10.0%
(0. 7 mL fill volume)
FDA-2015-P-4224 Flamingo PARAFON FORTE DSC Drug
Pharmaceuticals Ltd. (Chlorzoxazone Tablets,
500mg)
FDA-2015-P-4131 University of Florida Remove Oral Phenylephrine Drug

from the Final OTC Drug
Monograph
FDA-2015-P-4019 Hyman, Phelps & Potassium Chloride for Oral Drug
McNamara, P.C. Solution, 20 mEq
FDA-2015-P-3991 The Take Back America Medical and Recreational Drug

Campaign Marijuana
FDA-2015-P-3980 Teva Pharmaceutical Treanda (bendamustine Drug

Industries, Ltd. hydrochloride)
FDA-2015-P-3959 Daniel F. Kripke, MD Hypnotic Drug Labeling Drug
FDA-2015-P-3942 RegCon Solutions Chlorzoxazone Tablets Drug
FDA-2015-P-3876 World Alliance for FDA Mercury Amalgam Rule Medical

Mercury-Free Dentistry Device
FDA-2015-P-3794 Lawrence R. Savage Certain Medical Procedures Drug
FDA-2015-P-3778 Orthofix, Inc. Universal Device Identification Medical

Device
FDA-2015-P-3739 Bryan Kutz Xylitol when used in peanut/nut Food
butter products
FDA-2015-P-3621 Hospira Inc. VANCOLED (Vancomycin HCl Drug

for Injection)
FDA-2015-P-3540 Lachman Consultant ZAROXOLYN (metolazone) Drug

Services Inc. Tablets, 10 mg
FDA-2015-P-3485 National Chicken Broiler Hatcheries Food

Council, et al.
FDA-2015-P-3410 David K. Cundiff Anticoagulant Drug Drug

Contraindication
FDA-2015-P-3408 David K. Cundiff Anticoagulant Drug Drug

Contraindication
FDA-2015-P-3407 RegCon Solutions, LLC Diazepam Injection 10 mg/2mL Drug

(5mg/mL)
FDA-2015-P-3404 Lupin Pharmaceuticals, LIPTRUSET (ezetimibe and Drug

Inc. atorvastatin) Tablets 10 mg/10
mg, 10 mg/20 mg, 10 mg/40
mg, and 10 mg/80 mg
FDA-2015-P-3400 Lupin Pharmaceuticals, ANTIVERT (Meclizine HCl) Drug

Inc. Tables, 12.5 mg, 25 mg and 50
mg
FDA-2015-P-3391 Ms. Ashley Franz Nivea CoQ10 Cosmetics
FDA-2015-P-3365 Inrange Systems, Inc. Remote Medication Device

Management Systems
FDA-2015-P-3364 Dr. Leroy Hamilton "Return Receipt" Postcards Device
FDA-2015-P-3319 Winifred Begley MEVACOR (lovastatin) Tablets, Drug

20 mg and 40
FDA-2015-P-3299 Clinipace Worldwide THALITONE (chlorthalidone) Drug

Tablets, 15 mg
FDA-2015-P-3139 Kimberly Kideckel Garlic as an Ingredient or Food

Allergen on Food Labels
FDA-2015-P-3108 Ferrosan Medical Collagen-based absorbable Medical

Devices hemostatic devices Device
FDA-2015-P-3107 Ferrosan Medical Collagen-based Absorbable Medical

Devices Hemostatic Devices Device
FDA-2015-P-3085 Mid-Atlantic Rabies Virus - Priority Review Drug
BioTherapeutics, Inc. Voucher
FDA-2015-P-3053 Florek & Endres PLLC IZBA (travoprost) ophthalmic Drug

solution/drops 0.003%
FDA-2015-P-3020 Women's Voices for the Colorants in Feminine Hygiene Cosmetics

Earth Cosmetics
FDA-2015-P-3009 Physicians Committee Partially Hydrogenated Oils Food

for Responsible
Medicine
FDA-2015-P-2962 Regcon Solutions LLC Bromfenac Sodium Ophthalmic Drug
Solution/Drops eq. 0.09% acid
FDA-2015-P-2867 Lachman Consultant Capecitabine Tablets, 300 mg Drug

Services Inc.
FDA-2015-P-2854 Olsson, Frank, Weeda, VenaSeal Closure System Medical

Terman & Matz PC Device
FDA-2015-P-2830 Supernus OXTELLAR XR Drug

Pharmaceuticals (oxcarbazepine) Extended-
release Tablets
FDA-2015-P-2820 Center for Responsible NDA, IND & IDE Requirements Drugs &
Science Medical
Devices
FDA-2015-P-2807 Lachman Consultant Colchicine Capsules, 0.6 mg Drug
Services Inc.
FDA-2015-P-2736 Comodo Health, Inc. Argatroban Injection, 25 mg/25 Drug

mL, 50 mg/50 mL, and 100
mg/100 mL
FDA-2015-P-2678 Marlboro The Ice Diet Food
Gastroenterology PC
FDA-2015-P-2626 US WorldMeds, LLC Drug-Device Combo Products Drug

Containing Apomorphine for
Advanced Parkinson's Disease
FDA-2015-P-2482 Otsuka Pharmaceutical Aripiprazole Lauroxil Drug
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Commercialization, Inc.
FDA-2015-P-2481 SweetSpot Diabetes Diabetes Data Management Medical
Care Software Devices Device
FDA-2015-P-2413 Acura Pharmaceuticals, Abuse-Deterrent Immediate Drug

Inc. Release Oxycodone Tablets
FDA-2015-P-2375 Public Citizen. Seprafilm Bioresorbable Medical

Membrane Device
FDA-2015-P-2374 Hyman, Phelps & Abiraterone Acetate Tablets, Drug
McNamara PC 500mg
FDA-2015-P-2373 David K. Cundiff, MD Anticoagulant Drugs Drug
FDA-2015-P-2344 Lachman Consultant Oxycodone and Drug

Services Inc. Acetaminophen Tablets, 3.75
mg/300 mg and 8.75 mg/300
mg
FDA-2015-P-2247 Tricia Spencer Nutritional Data on Food Food

Labels
FDA-2015-P-2231 Bimeda Inc. Enrofloxacin Chewable Tablets Animal Drug
FDA-2015-P-2230 Hyman, Phelps & Esomeprazole Magnesium Drug

McNamara PC Delayed-Release Tablets, 20
mg (OTC)
FDA-2015-P-2149 Natural Solutions Informed Consent Drug
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FDA-2015-P-2142 Public Citizen HETLIOZ (tasimelteon) Drug

Capsules
FDA-2015-P-2141 Heritage Pharma Labs Verapamil HCl Tablets, 180 mg Drug

Inc.
FDA-2015-P-2120 Purdue Pharma L.P. Extended-release Oxycodone Drug
FDA-2015-P-2000 AbbVie, Inc. Biosimilars Labeling Biologic
FDA-2015-P-1977 Gerald Steel Fluoridation Chemical Additives Drug

& Fluoridated Drinking Waters
FDA-2015-P-1924 Hunton and Williams Zeltiq CoolSculpting System Medical

LLP Device
FDA-2015-P-1903 Matawan Tretinoin Cream, 0.0435% and Drug

Pharmaceuticals, LLC 0.0625%
FDA-2015-P-1900 CUNY School of Public DEPO PROVERA Drug

Health and Hunter (medroxyprogesterone acetate,
College DMPA) for Injection
FDA-2015-P-1899 Lachman Consultant Fluoxetine HCl Tablets, 60 mg Drug
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FDA-2015-P-1898 Hyman, Phelps & KYTRIL (granisetron HCl) Drug

McNamara, P.C. Tablets, EQ 1 mg and 2 mg
base
FDA-2015-P-1757 Organic and Natural CGMP Requirements Dietary
Health Association Supplement
FDA-2015-P-1752 Wiley Rein LLP ZUBSOLV (buprenorphine and Drug

naloxone sublingual tablets),
Eq. 11.4 mg/ 2.9 mg Base
Injection

Injection
FDA-2015-P-1674 Globus Medical Inc. UDI Implementation for Device

Orthopedic Implants
FDA-2015-P-1669 RegCon Solutions Acamprosate Calcium Drug

Delayed-release Tablets
FDA-2015-P-1595 Cubist DIFICID (fidaxomicin) Tablets Drug

FDA-2015-P-1590 Qilu Pharmaceutical Carfilzomib for injection, Drug

Co., Ltd. 10mg/vial and 30mg/vial
FDA-2015-P-1553 3M Drug Delivery Albuterol sulfate metered dose Drug

Systems inhalers
FDA-2015-P-1503 eVenus Pharmaceutical Thiotepa Injection 15mg/vial Drug

Laboratories Inc.
FDA-2015-P-1449 REGCON Solutions Phenylephrine HCl ophthalmic Drug

LLC solution/drops 2.5% and 10%
FDA-2015-P-1433 Michael Welber Genetically Modified Aedes Drug

Aegypti Mosquito
FDA-2015-P-1431 Teva Pharmaceuticals Treanda (bendamustine Drug

hydrochloride)
FDA-2015-P-1404 Physical RESTASIS (cyclosporine) Drug

Pharmaceutica, LLC Ophthalmic Emulsion, 0.05%
FDA-2015-P-1296 Jubilant DraxImage Compounded Drug

Radiopharmaceuticals
FDA-2015-P-1279 Cigar Rights of America Economic quantifier used for Tobacco

defining premium cigars
FDA-2015-P-1218 Hogan Lovells US LLP Visible particulate matter in Drug

parenteral drug products
FDA-2015-P-1201 Tate & Lyle Allulose Food
FDA-2015-P-1197 Stryker Medical Electric Positioning Chai Medical

Device
FDA-2015-P-1187 U.S. Right To Know Use of the term "Diet" as false Food
and misleading
FDA-2015-P-1153 Lachman Consultant Tylenol with Codeine Tablets Drug

Services, Inc. (acetaminophen with codeine
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325 mg/15 mg, 325 mg/30 mg,
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FDA-2015-P-1103 Hyman, Phelps & Bumetanide Tablets, 0.5 mg, 1 Drug

McNamara, P.C. mg, and 2 mg
FDA-2015-P-1094 Food and Water Watch Genetically Engineered Food

AquAdvantage Salmon
FDA-2015-P-1090 Baker Hostetler, LLP CORTIFOAM (hydrocortisone Drug

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FDA-2015-P-1050 Teva Neuroscience Inc. COPAXONE (Glatiramer Drug

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FDA-2015-P-1004 Lachman Consultant Aspirin and Codeine Drug

Services, Inc. Phosphate Tablets, 325 mg/15
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mg, and 325 mg/60 mg

mg, 300 mg/30 mg, 300 mg/45
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FDA-2015-P-0989 Organic Pastures Dairy Raw Butter Food

Company
FDA-2015-P-0876 The Escher Fund For 17 Hydroxy-Progesterone Drug

Autism Caproate
FDA-2015-P-0840 Dr. Richard Sherman Phosphorus Content in Drug Drug

Products
FDA-2015-P-0758 Orbicular Bimatoprost Ophthalmic Drug

Pharmaceutical Solution 0.03%
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FDA-2015-P-0732 Celgene Corporation ABRAXANE (paclitaxel protein- Drug
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FDA-2015-P-0720 Zydus Pharmaceuticals Methylphenidate HCl Extended Drug
Inc. Release Capsules, 60 mg
FDA-2015-P-0711 Larry Garner Allergen Extracts Drug
FDA-2015-P-0703 Sarah Salem-Robinson Laproscopic Power Medical

Morcellators Device
FDA-2015-P-0633 Dr. Jonathan Smith Drug Labeling - Headaches Drug
FDA-2015-P-0613 Qilu Pharma, Inc. Amikacin Sulfate Injection (EQ Drug

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FDA-2015-P-0596 Lachman Consultant Olmesartan Medoxomil Tablets, Drug

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FDA-2015-P-0578 Public Citizen’s Health Oral Ketoconazole Drug

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FDA-2015-P-0569 Koch Parafinczuk & Essure PMA Medical

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FDA-2015-P-0547 Gland Pharma Ltd. Ziprasidone Mesylate for Drug

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FDA-2015-P-0543 Gland Pharma Ltd. Calcitriol Injection, USP 1 Drug

mcg/mL and 2 mcg/mL

mg, 300 mg/30 mg, and 300
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FDA-2015-P-0464 Colgate Palmolive Anticaries OTC Drug Products Drug

Company Monograph
FDA-2015-P-0403 Lachman Consultant LEVOTHROID (levothyroxine Drug

Services, Inc. sodium) Tablets, 0.025 mg,
0.05 mg, 0.075 mg, 0.088 mg,
0.11 2 mg, 0.125 mg, 0.137
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mg, 0.2 mg, and 0.3 mg
FDA-2015-P-0389 Orbicular Bimatoprost Ophthalmic Drug

Pharmaceutical Solution 0.03%
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FDA-2015-P-0335 Chrai Associates, Inc. Gadopentetate Dimeglumine Drug
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FDA-2015-P-0233 Madison Company Tetrahydrozoline HCl, 0.01 to Cosmetics
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FDA-2015-P-0181 Mylan Specialty, L.P. EpiPen (epinephrine) Auto- Drug
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FDA-2015-P-0095 Leonhard Lang, GmbH Medical Device Tracking Medical

Requirements Exemption Device
FDA-2015-P-0065 Allergan, Inc. RESTASIS (Cyclosporine Drug

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FDA-2015-P-0059 Center For Science In Caffeine Dietary

The Public Interest Supplement
FDA-2015-P-0051 Inrange Systems Inc. Remote Medication Medical

Management System Device
FDA-2015-P-0014 LASIK Consumer Excimer Laser Labeling Medical

Advocates Device
Petition Tracker
Advisory Opinion 12/22/2015 Pending

Petition



ANDA Suitability
Petition
Citizen Petition - 12/16/2015 5/9/2016 Withdrawn
Listed Drug
Discontinuation

Citizen Petition - RLD 12/16/2015 12/9/2016 Denied

Designation
Advisory Opinion 12/9/2015 Pending

Petition



ANDA Suitability
Petition
ANDA Suitability
Petition
Listed Drug S/E Reasons;
Discontinuation & Granted
RLD Designation

Designation


Designation


Discontinuation
Listed Drug
Discontinuation

Designation

Discontinuation

Listed Drug
Discontinuation

Discontinuation
Discontinuation


Discontinuation

Designation

ANDA Suitability
Petition


Designation

ANDA Suitability
Petition



ANDA Suitability
Petition

ANDA Suitability
Petition

ANADA Suitability
Petition
ANDA Suitability
Petition

Designation



Listed Drug
Discontinuation
ANDA Suitability
Petition

Designation

Discontinuation

Listed Drug
Discontinuation


Designation


ANDA Suitability
Petition

Designation

Designation


Citizen Petition 4/16/2015 5/5/2016 Response - Closed


Discontinuation

Designation


ANDA Suitability
Petition

ANDA Suitability
Petition

Designation


Designation
Denied in Part
Citizen Petition - RLD 2/25/2015 5/16/2016 Granted in Part;

Designation Denied in Part

ANDA Suitability
Petition

ANDA Suitability
Petition

Designation

ANDA Suitability
Petition

Listed Drug
Discontinuation &
RLD Designation

Designation

ANDA Suitability
Petition


FDA-2014-P-2301 Probiomed S.A. de C.V. PROBIOGLA-r (glatiramer Drug

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FDA-2014-P-2276 Alan Laboratories, Inc. SANCTURA (trospium chloride) Drug

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FDA-2014-P-2243 Apotex Inc. Atropine Sulfate Ophthalmic Drug
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FDA-2014-P-2193 Acorda Therapeutics AMPYRA (dalfampridine) Drug

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FDA-2014-P-2188 Acura Pharmaceuticals Abuse-Deterrent Immediate Drug

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FDA-2014-P-2169 Lachman Consultant Aspirin 300 mg, Butalbital 50 Drug

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FDA-2014-P-2168 Lachman Consultant Aspirin 300 mg, Butalbital 50 Drug
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FDA-2014-P-2142 Zydus Pharmaceuticals Atropine Sulfate Injection USP, Drug

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FDA-2014-P-2140 Lachman Consultant Thiotepa for Injection 100 Drug
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FDA-2014-P-2058 Lachman Consultant BuprenorphineHCl and Drug

Services, Inc Naloxone HCl Sublingual Film
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FDA-2014-P-2035 Dr. Carla M. Davis Sesame Based Ingredient Food
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FDA-2014-P-1883 Lannett Holdings Inc. LEVATOL (penbutolol sulfate) Drug

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FDA-2014-P-1882 Isabella Guajardo Folic acid fortification in Latino Food

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FDA-2014-P-1844 Lachman Consultant Chlorpromazine HCl Tablets, Drug

FDA-2014-P-1802 e5 Pharma, LLC Methimazole Oral Solution Animal Drug
FDA-2014-P-1796 Omthera EPANOVA (omega-3-carboxylic Drug

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FDA-2014-P-1784 Wood Burditt Group Drug Irradiation Drug
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FDA-2014-P-1771 Amgen, Inc. BPCIA Implementation Biologics
FDA-2014-P-1753 Angela Stanton, Ph.D. CIPRO (Ciprofloxacin) Drug
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FDA-2014-P-1685 Larry R. Pilot OTC Oral Contraceptives Drug
FDA-2014-P-1673 Tia Gonnella High Level Disinfectant Drug
FDA-2014-P-1670 Gordon Johnston Atropine Sulfate Injection USP, Drug

Regulatory Consultants 0.4 mg/ml, 20 ml multiple-dose
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FDA-2014-P-1660 Teva Respiratory LLC QVAR (beclomethasone Drug
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FDA-2014-P-1657 Gordon Johnston K-TAB (Potassium Chloride Drug
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FDA-2014-P-1656 Alaska Seafood Golden King Crab Food
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FDA-2014-P-1650 Consumers Union Use of "Natural" Label on Food Food
FDA-2014-P-1649 Spectrum FUSILEV (levoleucovorin) for Drug

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FDA-2014-P-1622 Genesee Health Clozapine REMS Drug

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FDA-2014-P-1615 Spectrum FUSILEV (levoleucovorin) for Drug

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FDA-2014-P-1611 Southern Network on LEVAQUIN (levofloxacin) Drug

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FDA-2014-P-1603 Zydus Pharmaceuticals Voriconazole Injection, 10 Drug

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FDA-2014-P-1593 Ferring PREPOPIK (citric acid; Drug

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FDA-2014-P-1576 Gordon Johnston Sulfacetamide Sodium Drug
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FDA-2014-P-1570 Natural Solutions Nano Silver - Ebola Dietary
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FDA-2014-P-1569 Pharmacists Planning VIAGRA (Sildenafil Citrate) Drug

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FDA-2014-P-1562 Institute for Safe CHANTIX (varenicline) Tablets Drug

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FDA-2014-P-1483 Upsher-Smith NAMENDA (memantine HCl) Drug

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FDA-2014-P-1472 Strides Arcolab Limited, NAMENDA (memantine HCl) Drug

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FDA-2014-P-1470 Hyman, Phelps & Thiotepa for Injection, 15 Drug
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FDA-2014-P-1429 Oliver Boudreaux Natamycin GRAS Status Food
FDA-2014-P-1383 Lachman Consultant Buprenorphine HCl & Naloxone Drug

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FDA-2014-P-1354 Otsuka Aripiprazole Lauroxil Drug
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FDA-2014-P-1353 International Formula Infant Formula Food
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FDA-2014-P-1343 American Society of Epidural Corticosteroid Drug

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FDA-2014-P-1302 Duchesnay Inc. DICLEGIS (doxylamine Drug
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FDA-2014-P-1293 Hyman, Phelps & HyQvia (Immune Globulin Biologics
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FDA-2014-P-1282 Morgan Lewis & Isotretinoin Capsules, 15 mg, Drug
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FDA-2014-P-1281 Arnell Golden Gregory Ophthalmic Mitomycin-c Drug

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FDA-2014-P-1269 Pfizer Inc. QUILLIVANT XR Drug

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FDA-2014-P-1256 Public Citizen OTC Benzocaine Drug Drug

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FDA-2014-P-1102 Lachman Consultant LOESTRIN FE 1/20 (ethinyl Drug

Services, Inc. estradiol ;norethindrone
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FDA-2014-P-1101 Lachman Consultant LOESTRIN 21 1/20 (ethinyl Drug

Services, Inc. estradiol;norethindrone
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FDA-2014-P-1065 Zydus Pharmaceuticals DUAC (clindamycin phosphate Drug
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FDA-2014-P-1057 Pharmacists Planning CHANTIX (varenicline) Tablets Drug

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FDA-2014-P-1044 Zydus Pharmaceuticals Mercaptopurine Tablets Drug

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FDA-2014-P-1038 Lachman Consultant Amphetamine Sulfate Tablets, Drug

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FDA-2014-P-0984 Lachman Consultant Bisoprolol Fumarate and Drug
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FDA-2014-P-0980 Lachman Consultant REYATAZ (atazanavir sulfate) Drug

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FDA-2014-P-0979 Emcure DIAMOX (acetazolamide) Drug

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FDA-2014-P-0935 The Juice Products Coconut Water Food
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FDA-2014-P-0933 Teva Neuroscience Inc. COPAXONE (Glatiramer Drug

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FDA-2014-P-0919 Daniel Schumaier, Hearing Aid Devices and Medical

Ph.D. Personal Sound Amplification Device
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FDA-2014-P-0916 Hope Pharmaceuticals Sodium Nitrite & Sodium Drug
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FDA-2014-P-0908 Mothers Against Dental Amalgum Medical

Mercury Device
FDA-2014-P-0907 Mothers Against Dental Amalgum Medical

Mercury Device
FDA-2014-P-0878 Amarin Pharma Inc. VASCEPA (icosapent ethyl) Drug

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FDA-2014-P-0862 Alliance for Natural Ban the use of Phthalates in all Drug
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FDA-2014-P-0861 Clinipace Worldwide FOSAMAX (alendronate Drug

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FDA-2014-P-0856 Southern Network on LEVAQUIN (levofloxacin) Drug
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FDA-2014-P-0831 Orthofix Inc. Instruments in the control of Medical

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FDA-2014-P-0830 Merz North America CUVPOSA (glycopyrrolate) Drug

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FDA-2014-P-0825 Orthofix Inc. Implants in the control of third Medical
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FDA-2014-P-0823 Richard D. Burk Baking Soda Drug
FDA-2014-P-0814 Center for Responsible Clinical Trial Informed Consent Drug

Science
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FDA-2014-P-0802 Moon T. Kwon Personal Sound Amplification Medical

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FDA-1975-N-0012 American Cleaning Food Handler Antiseptic Drug

Institute and Personal Handwash OTC Drug Products
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FDA-2014-P-0794 E5 Pharma LLC Methimazole Film-Coated Drug
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FDA-2014-P-0773 Pharmacists Planning Dibutyl-Phthalates and other Drug

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FDA-2014-P-0772 Piedmont Animal Health Pimobendan Soft Chewable Drug

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FDA-2014-P-0771 Hope Pharmaceuticals Sodium Nitrite & Sodium Drug

Thiosulfate Drugs
FDA-2014-P-0752 Pharmacists Planning Oral & Nasal Naloxone BTC Drug

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FDA-2014-P-0748 Piedmont Animal Health INTERCEPTOR (milbemycin Animal Drug

oxime) FLAVOR TABS
FDA-2014-P-0737 Pfizer Inc. DUAVEE (conjugated Drug

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FDA-2014-P-0724 Rocky Mountain Exemption Medical
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FDA-2014-P-0699 Jason Williams LOVAZA (omega-3-acid ethyl Drug
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FDA-2014-P-0687 Margaret A. Moline Import alerts #80-06 and #89- Medical

08 Device
FDA-2014-P-0654 Edwards Lifesciences SAPIEN XT THV - QSR Medical

LLC Variance (Certificate to Foreign Device
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FDA-2014-P-0648 InovoBiologic PolyGiycopleX as a New Food
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FDA-2014-P-0647 Kamat Pharmatech Metoprolol Tartrate Oral Drug

Solution (10 mg/mL)
FDA-2014-P-0646 Kamat Pharmatech Trazodone Hydrochloride Oral Drug

Solution (10 mg/mL)
FDA-2014-P-0637 Lachman Consultant FUSILEV (levoleucovorin Drug

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FDA-2014-P-0628 Shauce Company Use of "Healthy" on Hot Food
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FDA-2014-P-0603 Pacific Link Consulting Diazepam Nasal Spray Drug
FDA-2014-P-0594 Hyman, Phelps & Ranbaxy Laboratories, Ltd. Drug

McNamara, P.C. 180-Day Exclusivity
FDA-2014-P-0585 Capstone Law APC Welch's 100% Grape Juice Food

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FDA-2014-P-0534 Neurelis Inc. Diazepam Nasal Spray Drug
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FDA-2014-P-0462 Wiley Rein LLP Amantadine HCl Capsules, 200 Drug

mg
FDA-2014-P-0461 Wiley Rein LLP Amantadine HCl Capsules, 200 Drug

mg
FDA-2014-P-0446 Starkist Company Sardine Food
FDA-2014-P-0445 Robert L. Lytle Private Membership Misc

Associations
FDA-2014-P-0427 Medicem Technology DILIPAN-S Medical

Device
FDA-2014-P-0422 Jason R. Williams LOVAZA (omega-3-acid ethyl Drug

esters) Capsules
FDA-2014-P-0417 Greenblum & Bernstein, Doxorubicin HCl (Liposomal) Drug

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FDA-2014-P-0407 Almatica Pharma, Inc. NAPRELAN (naproxen Drug

sodium) Extended-release
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FDA-2014-P-0405 Ken Surprenant Fluorouracil Drug
FDA-2014-P-0404 Teva Respiratory, LLC ProAir HFA (albuterol sulfate) Drug

Inhalation Aerosol
FDA-2014-P-0377 Hyman, Phelps & ACTHAR GEL SYNTHETIC Drug

McNamara, P.C. (seractide acetate) Injection
FDA-2014-P-0367 Hyman, Phelps & Cantharidin Bulk Drug Drug

McNamara, P.C. Substance/Compounding
FDA-2014-P-0328 Hyman, Phelps & K-TAB (potassium chloride Drug

McNamara, P.C. extended release tablets,
USP), 20 meq
FDA-2014-P-0318 Antares Pharma, Inc. OTREXUP (methotrexate) Drug
Injection
FDA-2014-P-0315 Lachman Consultant FUSILEV (levoleucovorin Drug

Services Inc. calcium) Injection, 250 mg/25
mL
FDA-2014-P-0312 Grocery Manufatcurer's Regulation re Labeling Food
Association Products as "Natural"
FDA-2014-P-0311 Sheppard, Mullen, Phenylephrine HCl, USP, 10 Drug

Richter, & Hampton LLP mg/mL, in a 5 mL Glass Vial

FDA-2014-P-0290 Leroy L. Hamilton Product Code Use Drug
FDA-2014-P-0284 Lachman Consultant Cisplatin Injection 1 mg/mL, in Drug

Services, Inc. strengths of 10 mg/10 mL and
25 mg/25 mL
FDA-2014-P-0283 Leroy L. Hamilton Medical Device Classification Medical
Device
FDA-2014-P-0282 Custo Pharm, Inc. Ceftazidime for Injection, 3 Drug

gram/vial
FDA-2014-P-0263 Ferrero U.S.A., Inc. RACC for Nut Cocoa Based Food
Spreads
FDA-2014-P-0259 Sabra Dipping Co., LLC Hummus Standard of Identity Food
FDA-2014-P-0258 Public Citizen Testosterone Drugs Drug
FDA-2014-P-0251 Gordon Johnston Leucovorin Injection USP Drug

Regulatory Consultants, (preservative free), 50 mg/ 5
LLC mL, 200 mg/20 mL and 350
mg/35 mL
FDA-2014-P-0245 The Sugar Association, "Sugar" in Food and Beverage Food

Inc. Labeling
FDA-2014-P-0241 Public Citizen Testosterone Drugs Drug
FDA-2014-P-0231 Adaptive Engineering Manually Operated Portable Medical

Inc Wheelchair Lifts Device
FDA-2014-P-0230 Lachman Consultant RESCULA (Unoprostone Drug
Services, Inc. Isopropyl) Ophthalmic Solution,
15%
FDA-2014-P-0210 Greenblum & Bernstein, Doxorubicin HCl (Liposomal) Drug
P.L.C. Injection
FDA-2014-P-0209 Horizon Pharma, Inc. VIMOVO Drug

(naproxen/esomeprazole
magnesium) Delayed-release
Tablets
FDA-2014-P-0206 Roger Cady et al. Migraine Drug Labeling Drug
FDA-2014-P-0205 Purdue Pharma LP IR Opioid Analgesics Drug
FDA-2014-P-0196 Lannett Company, Inc. Hydromorphone HCl Tablets, 1 Drug

mg (scored tablets)
FDA-2014-P-0181 Imagenetix, Inc. BLIS K12 Drug/Dietary

Supplement
FDA-2014-P-0169 Strides Inc. THIOPLEX (thioepa) Injection, Drug

15mg/vial
FDA-2014-P-0159 Mead Killion Personal Sound Amplification Medical

Products Device
FDA-2014-P-0158 Christohper Schweitzer Personal Sound Amplification Medical

Products Device
FDA-2014-P-0144 Sucampo Pharma AMITIZA (lubiprostone) Drug

Americas, LLC Capsules
FDA-2014-P-0143 Gail Gudmundsen Personal Sound Amplification Medical

Products Device
FDA-2014-P-0142 Emcure Pantoprazole Sodium for Drug

Pharmaceuticals USA Injection USP
Inc.
FDA-2014-P-0123 Consumer Reports Food Color Additive "Caramel Food
Color"

FDA-2014-P-0112 NadaChair Product Regulation Medical

Device
FDA-2014-P-0111 LeMaitre Vascular Inc. Reclassification Petition for Medical
Animal Tissue Graft Device
FDA-2014-P-0099 Apotex Corp. NAMENDA XR (Memantine Drug

HCl Extended-Release
Capsules)
FDA-2014-P-0077 Janssen Pharma Biosimilar Naming Biologics
Companies
FDA-2014-P-0076 Lannett Company, Inc. Hydromorphone HCl Oral Drug

Solution, 1 mg per 5 mL
FDA-2014-P-0073 Jubilant Life Sciences Travoprost Ophthalmic Solution Drug

Limited
FDA-2014-P-0038 Riverain Technologies Reclassification Petition for Medical

ClearRead + Detect CADe Device
Device
Petition Tracker
Citizen Petition - RLD 12/23/2014 9/12/2016 Granted in part;

Designation Denied in part

Designation



ANDA Suitability
Petition
ANDA Suitability
Petition

ANDA Suitability
Petition
ANDA Suitability
Petition
ANDA Suitability
Petition
Citizen Petition 11/25/2014 5/27/2015 Interim response

ANADA Suitability
Petition
Designation

Discontinuation
Discontinuation
Citizen Petition - RLD 11/5/2014 5/12/2015 Interim response

Designation

ANADA Suitability
Petition



ANADA Suitability
Petition

ANDA Suitability
Petition
Citizen Petition 10/20/2014 5/20/2015 Granted in part;
Denied in part

Designation



ANDA Suitability
Petition
Citizen Petition - RLD 10/9/2014 3/31/2015 Interim response

Designation

Listed Drug
Discontinuation
Listed Drug
Discontinuation
Designation

ANDA Suitability
Petition
ANDA Suitability
Petition

Denied in part


ANDA Suitability
Petition

(505(q) Certification) Denied in part
Citizen Petition 7/28/2014 1/--/2014 Interim response
Citizen Petition - 7/28/2014 1/9/2015 Denied (Moot)

Listed Drug
Discontinuation
Citizen Petition - 7/28/2014 1/9/2015 Denied (Moot)

Listed Drug
Discontinuation
Designation

Designation

ANDA Suitability
Petition
ANDA Suitability
Petition

Discontinuation
Discontinuation




Discontinuation


ANDA Suitability
Petition

ANADA Suitability
Petition

ANADA Suitability
Petition

ANADA Suitability
Petition
(505(q) Certification

ANDA Suitability
Petition

ANDA Suitability
Petition
ANDA Suitability
Petition
Discontinuation


Discontinuation

ANDA Suitability
Petition
Citizen Petition - RLD 4/21/2014 4/18/2016 Granted in part;
Designation Denied in part

Denied in part

ANDA Suitability
Petition
ANDA Suitability
Petition

Reclassification
Citizen Petition 4/10/2014 Withdrawn


Denied in part

(505(q) Certification Denied in part
Citizen Petition - 4/1/2014 1/23/2017 Discontinued for S/E

Listed Drug Reasons
Discontinuation

Designation

Discontinuation

ANDA Suitability
Petition

ANDA Suitability
Petition

ANDA Suitability
Petition


ANDA Suitability
Petition
Citizen Petition 2/14/2014 10/10/2014 Pending

Designation

Citizen Petition 2/19/2014 Granted in part;

Denied in part
Citizen Petition - 1/9/2014 3/22/2016 Pending

ANDA Suitability
Petition

Designation & Listed
Drug Discontinuation


ANDA Suitability
Petition



Denied in part

ANDA Suitability
Petition
Designation

FDA-2013-P-1711 Morgan Lewis Bockius Hydrocodone Combination Drug

LLP Products Split Scheduling
FDA-2013-P-1710 Noven DAYTRANA (Methylphenidate) Drug

Pharmaceuticals, Inc. Transdermal System
FDA-2013-P-1654 Gordon Johnston Leucovorin Calcium Injection- Drug

Regulatory Consultants, Preservative Free, 10 mg/lmL,
LLC 10 mL total fill volume
FDA-2013-P-1641 Teva Neuroscience COPAXONE (Glatiramer Drug
Acetate) Injection
FDA-2013-P-1640 Hyman, Phelps & OTC Transdermal Nicotine Drug

McNamara, P.C. Patches
FDA-2013-P-1637 Melissa Burdick LEMTRADA (alemtuzumab) Drug
FDA-2013-P-1636 Lannett Company, Inc. Hydromorphone HCl Tablets, 1 Drug

mg (scored tablets) and
Hydromorphone HCl Oral
Solution, 1 mg per 5 mL.
FDA-2013-P-1623 Sigmapharm SAPHRIS (Asenapine Maleate) Drug

Laboratories, LLC Sublingual Tablets
FDA-2013-P-1614 Alliance of African Shea Standards of Identity for Food

Associations Chocolate
FDA-2013-P-1612 EPA Drug Initiative VASCEPA (icosapent ethyl) Drug

Capsules
FDA-2013-P-1611 Clarissa Clarke Tooth Shade Resin Material & Medical

Ultraviolet Activator Special Device
Controls
FDA-2013-P-1609 Lachman Consultant LUPRON DEPOT (leuprolide Drug
Services, Inc. acetate for depot suspension)
Injection
FDA-2013-P-1606 Pharmacists Planning Add drug abuse deterrent Drug
Services, Inc. technology to all hydrocodone
schedule II products
FDA-2013-P-1552 Hearing Industries Reclassification Petition for Medical

Association Wireless Air Conduction Device
Hearing Aids
FDA-2013-P-1516 Spectron mrc, LLC Sodium Pertechnetate Tc-99m Drug
(technetium Tc-99m sodium
pertechnetate)
FDA-2013-P-1515 Lachman Consultant ZOVIRAX (acyclovir sodium) Drug
Services, Inc. for Injection, eq. 1 g base/vial
FDA-2013-P-1512 PetaStrip LLC Ivermectin Soluble Film Animal Drug

(HEARTGUARD Tablets)
FDA-2013-P-1511 PetaStrip LLC Ivermectin Soluble Film Animal Drug

(HEARTGUARD Tablets for
Cats)
FDA-2013-P-1510 Lachman Consultant LUPRON DEPOT-PED Drug
Services, Inc. (leuprolide acetate for depot
suspension), 3.75 mg/vial and
7.5 mg/vial
FDA-2013-P-1509 Dr. S. Albert Edward Common Module 1 * for the Drug

eCTD/RPS
FDA-2013-P-1508 Cadence OFIRMEV (acetaminophen Drug

Pharmaceuticals, Inc. injection)
FDA-2013-P-1507 Dr. S. Albert Edward Uniformly Institute Single Drug

Webtrader Accounts
FDA-2013-P-1505 Teva Respiratory, LLC ProAir HFA (albuterol sulfate) Drug

Inhalation Aerosol

FDA-2013-P-1398 Novartis Group Biosimilar Naming Biologics
FDA-2013-P-1397 UCB, Inc. VIMPAT (lacosamide) Drug
FDA-2013-P-1379 Lachman Consultant PREZISTA (darunavir) Tablets, Drug

FDA-2013-P-1378 William L. Schwemer Homeopathic Drugs Drug
FDA-2013-P-1377 Covis Pharma Sarl LANOXIN (digoxin) Tablets Drug
FDA-2013-P-1376 Covis Pharma Sarl LANOXIN (digoxin) Tablets Drug
FDA-2013-P-1375 Purdue Pharma L.P. OXYCONTIN (oxycodone HCl) Drug

FDA-2013-P-1374 Pharmacists Planning Cell Phone Radiation Device

Service, Inc.
FDA-2013-P-1373 Terry L. Tennant QSR Requirements Device
FDA-2013-P-1297 Harmony Cone Ear Ear Candles Device

Candles
FDA-2013-P-1296 Lannett Company, Inc. DIAMOX SEQUELS Drug

(acetazolamide) Extended-
release Capsules
FDA-2013-P-1294 Luitpold INJECTAFER (ferric Drug
Pharmaceuticals Inc. carboxymaltose injection)
FDA-2013-P-1293 United Therapeutics REMODULIN (treprostinil) Drug

Corp. Injection
FDA-2013-P-1292 Sun Pharmaceutical Ganirelix Acetate Injection Drug

Industries, Ltd.
FDA-2013-P-1291 American Herbal FDA Inspections Dietary

Products Association Supplement
FDA-2013-P-1290 G. Pohl-Boskamp NITROLINGUAL PUMPSTRAY Drug

GmbH & Company KG (nitroglycerin lingual spray)
FDA-2013-P-1289 National Advocates for Extended-release and Long- Drug

Pregnant Women acting Opioid Analgesics
FDA-2013-P-1288 National Advocates for Extended-release and Long- Drug

Pregnant Women acting Opioid Analgesics
FDA-2013-P-1287 Aptalis Pharma US, Inc. CANASA (mesalamine) Rectal Drug

Suppositories
FDA-2013-P-1286 Proctor & Gamble OTC Proton Pump Inhibitors Drug
Company
FDA-2013-P-1283 Horizon Pharma, Inc. RAYOS (prednisone) Delayed- Drug

release Tablets
FDA-2013-P-1203 McGuireWoods LLP Ropivacaine HCl Injection Drug

(2mg/mL in a 500mL infusion
bag)
FDA-2013-P-1202 Olsson Frank Weeda Vancomycin Hydrochloride Drug
Terman Matz PC USP, 1.5 grams (base)/vial
FDA-2013-P-1199 CorePharma, LLC SKELAXIN (metaxalone) Drug

Tablets, 400 mg
FDA-2013-P-1153 Generic Pharmaceutical Biosimilar Naming Biologics

Association
FDA-2013-P-1128 Teva Pharmaceutical COPAXONE (Glatiramer Drug

Industries Ltd Acetate) Injection
FDA-2013-P-1127 Tobacco Control Legal Regulation of Non-cigarette Tobacco

Consortium Tobacco Products Products
FDA-2013-P-1126 Lachman Consultant Capecitabine Tablets, 300 mg Drug

Services, Inc. and 1000 mg
FDA-2013-P-1101 Piedmont Animal Health Clindamycin HCl Soft Animal Drug

Chewable Tablets
FDA-2013-P-1082 Horizon Pharma, Inc. RAYOS (prednisone) Delayed- Drug

release Tablets
FDA-2013-P-1080 Reginald Burgess External Prosthetics Medical

Device
FDA-2013-P-1079 Medical Information Manufacturer Communications Drugs and

Working Group About Off-Label Uses Medical
Devices
FDA-2013-P-1078 Parnell Technologies GONABREED (gonadorelin) Animal Drug

Pty Ltd
FDA-2013-P-1061 Navinta LLC Ganciclovir Injection, 500 Drug

mg/10 ml (50mg/mL)
FDA-2013-P-1058 IntelGenx Corp. Rizatriptan Oral Film (MAXALT- Drug
MLT)
FDA-2013-P-1056 Public Citizen Clopidogrel Drug
FDA-2012-E-0196 Sterne, Kessler, Sapien Transcatheter Heart Medical

Goldstein & Fox PLL Valve Device
FDA-2013-P-1055 Actavis Elizabeth LLC SUBUTEX (buprenorphine Drug

HCl) Sublingual Tablets, EQ. 2
mg and 8 mg Base
FDA-2013-P-1002 Zydus Pharmaceuticals Imatinib Mesylate Tablets, 300 Drug
Inc. mg
FDA-2013-P-1001 Weill Cornell Medical OTC drugs products containing Drug

College an ingredient with
anticholinergic or histamine H1
inverse agonist effects
FDA-2013-P-1000 Eclat Pharmaceuticals, Neostigmine Methylsulfate Drug

LLC Injection
FDA-2013-P-0999 Consumer Healthcare Acetaminophen OTC Drug Drug

Products Association Labeling
FDA-2013-P-0998 Millennium VELCADE (bortezomib) for Drug

Pharmaceuticals, Inc. Injection
FDA-2013-P-0997 Thomas J. Quinn Nuclear Magnetic Resonance Medical

Imaging Device
FDA-2013-P-0996 Piedmont Animal Health Cefpodoxime Proxetil Soft Animal Drug

Chewable Tablet
FDA-2013-P-0995 Monosol Rx, Inc. Buprenorphine and Naloxone Drug

Sublingual Film
FDA-2013-P-0990 Corporate Social Use of Metoclopramide in Drug

Responsibility Advocate Force-Feeding at Guantánamo
(Reprieve) Bay
FDA-2013-P-0949 Garrett Skelly C-LEG Medical
Device
FDA-2013-P-0948 Pharmaceutics STAVZOR (valproic acid) Drug

International Delayed-release Capsules
Incorporated
FDA-2013-P-0947 Hyman, Phelps & Cefdinir for Oral Suspension Drug
Mc.Namara, P.C
FDA-2013-P-0946 Lachman Consultant Hydrocodone Bitartrate and Drug

Services, Inc. Acetaminophen Tablets USP,
2.5 mg/300 mg
FDA-2013-P-0945 Lachman Consultant Carisoprodol Tablets, 300 mg Drug
Services, Inc.
FDA-2013-P-0944 Jeffrey G. Thomas DBA DURASEAL Spinal Sealant Medical

Thomas Law Company Device
FDA-2013-P-0886 Arnall Golden Gregory NORPLANT II Levonorgestrel Drug

LLP Implants (JADELLE)
FDA-2013-P-0885 AMAG FERAHEME (ferumoxytol) Drug

Pharmaceuticals, Inc. Injection
FDA-2013-P-0884 Eisai Inc. BELVIQ (lorcaserin HCl) Drug

Tablets and FYCOMPA
(perampanel) Tablets
FDA-2013-P-0862 Spec Pharma, LLC BetaVet (Corticosteroid) Animal Drug
FDA-2013-P-0850 Teva Pharmaceutical ProAir® HFA (albuterol sulfate) Drug

Industries, Ltd. Inhalation Aerosol
FDA-2013-P-0849 Hyman, Phelps & Ampicillin for Injection lg and Drug

Mc.Namara, P.C 2g in ADD-Vantage Vial
FDA-2013-P-0848 Hyman, Phelps & Oxacillin for Injection lg and 2g Drug

Mc.Namara, P.C in ADD-Vantage Vial
FDA-2013-P-0847 Lachman Consultant ZANAFLEX (Tizanidine HCl) Drug

Services, Inc. Tablets
FDA-2013-P-0846 K&L Gates, L.L.P KUVAN (sapropterin Drug

dihydrochloride) Tablets
FDA-2013-P-0830 Lachman Consultant Hydromorphone HCI Drug

Services, Inc. Extended-Release Tablets, 24
mg (EXALGO)
FDA-2013-P-0813 Lachman Consultant Hydrocodone Bitartrate and Drug
Services, Inc. Acetaminophen Tablets, 4
mg/300 mg, 6 mg/300 mg, and
8 mg/300 mg
FDA-2013-P-0800 Lachman Consultant Dapsone Tablets Drug
Services, Inc.
FDA-2013-P-0799 Lachman Consultant GRIS-PEG (griseofulvin Drug
Services, Inc. ultramicrosize) Tablets
FDA-2013-P-0776 Biotechnology Unique Names for Approved Biologics

Information Institute Biological Products
FDA-2013-P-0775 Hyman, Phelps & INVEGA (paliperidone) Drug

McNamara, P.C. Extended-release Tablets
FDA-2013-P-0769 Lachman Consultant Bendamustine Hydrochloride Drug

Services, Inc. for Injection, 200 mg/vial
FDA-2013-P-0768 Salus Pharma LLC ZEFAZONE (cefmetazole Drug

sodium) Injection
FDA-2013-P-0767 Ascend Laboratories, PROGRAF (tacrolimus) Drug

LLC Capsule & Injection
FDA-2013-P-0766 Amedra ALBENZA (albendazole) Drug

Pharmaceuticals LLC Tablets
FDA-2013-P-0761 Poly Cell Technologies Glucagel barley betaglucan Food

LLC fiber
FDA-2013-P-0735 Mario Morais Cerebrospinal Venous Medical

Insufficiency Procedure Device
FDA-2013-P-0711 Allergy & Asthma Rx/OTC Asthma and Drug

Network Mothers of Anaphylaxis Medications
Asthmatics
FDA-2013-P-0703 Center for Lawful Abuse-Deterrent Opioids Drug
Access and Abuse
Deterrence
FDA-2013-P-0701 Organic PasturesDairy Raw Milk/Raw Dairy Products Food
Co. LLC
FDA-2013-P-0695 Steven A. Zecola Metastatic Cancer Drug
FDA-2013-P-0694 Elite Laboratories, Inc Dexbrompheniramine Maleate Drug

and Pseudoephedrine Sulfate
Extended-release Tablets, 6
mg/120 mg
FDA-2013-P-0693 Center for Medicine in TREANDA (bendamustine) for Drug
the Public Interest Injection
FDA-2013-P-0675 Lachman Consultant ULTRACET (tramadol and Drug
Sevices, Inc.n acetaminophen) Tablets, 37.5
mg/325 mg
FDA-2013-P-0671 Lachman Consultant PARAFLEX (chlorzoxazone) Drug
Services, Inc. Tablets
FDA-2013-P-0670 Altaire GENTAK (gentamicin sulfate) Drug

Pharmaceuticals, Inc. Ophthalmic Solution, EQ 0.3%
base
FDA-2013-P-0667 American Clinical Laboratory Developed Tests Medical
Laboratory Association Device
FDA-2013-P-0666 Mutual Pharmaceutical FELDANE (piroxicam) Drug

Company, Inc. Capsules
FDA-2013-P-0665 Arnall Golden Gregory INTAL (cromolyn sodium) Drug

LLP Inhalation Capsule
FDA-2013-P-0664 Watson Laboratories, CRINONE (progesterone gel) Drug

Inc. 4% and 8%
FDA-2013-P-0632 Piedmont Animal Health ANTIROBE (clindamycin HCl) Animal Drug

Capsules
FDA-2013-P-0631 CorePharma, LLC MOBAN (molindone HCL) Drug

Tablets
FDA-2013-P-0615 State of California Hearing Aid Dispensers Medical

Department of Device
Consumer Affairs
FDA-2013-P-0608 Janssen Research and INVEGA SUSTENNA Drug
Development, L.L.C. (paliperidone palmitate)
Extended-release Injectable
Suspension
FDA-2013-P-0574 Watson Laboratories, RAPAFLO (Silodosin) Drug

Inc. Capsules
FDA-2013-P-0573 Lupin Pharmaceuticals, BANZEL (rufinamide) Tablets Drug

Inc.
FDA-2013-P-0572 Prometheus LOTRONEX (alosetron Drug

Laboratories Inc. hydrochloride) Tablets - Shared
REMS
FDA-2013-P-0522 Escher Fund for Autism DICLEGIS (doxylamine Drug

succinate and pyridoxine
hydrochloride) Delayed-release
Tablets
FDA-2013-P-0509 Skadden, Arps, Slate, Immunosuppressants for Drug
Meagher & Flom LLP Maintenance Therapy
Following Renal Transplant
FDA-2013-P-0506 Nomax, Inc. UROCIT-K Powder (potassium Drug

citrate)
FDA-2013-P-0505 Nomax, Inc. Fluorescein Strips Drug

citrate)

citrate)
FDA-2013-P-0493 Altaire AK-FLUOR 25% (fluorescein Drug

Pharmaceuticals, Inc. sodium) Injection
FDA-2013-P-0472 Richard C. Theuer, GRAS Status of Carrageenan Foods

Ph.D.
FDA-2013-P-0471 Bayer HealthCare NATAZIA (estradiol valerate Drug

Pharmaceuticals Inc. and estradiol
valerate/dienogest) Tablets
FDA-2013-P-0470 Salix Pharmaceuticals, APRISO (mesalamine) Drug

Inc. Extended-release Capsules
FDA-2013-P-0435 Tobacco Control Legal Prohibit Menthol as a Tobacco

Consortium, et al Characterizing Flavor in Products
Cigarettes
FDA-2013-P-0426 Shotwell & Carr, Inc. ATOPICA (cyclosporine) Animal Drug
FDA-2013-P-0425 Rhodes Technologies Oxycodone HCl API Drug
FDA-2013-P-0424 Actelion VENTAVIS (iloprost) Inhalation Drug

Pharmaceuticals Ltd. Solution
FDA-2013-P-0408 Chesapeake Regulatory Intraperitoneal Solutions Drug

Group, Inc.
FDA-2013-P-0380 Univ of Florida College Medroxyprogesterone Acetate Drug

of Medicine/UNC
School of Medicine
FDA-2013-P-0371 Auxilium TESTIM (testosterone Drug

Pharmaceuticals, Inc. transdermal gel 1%)
FDA-2013-P-0371 Auxilium TESTIM (testosterone Drug
Pharmaceuticals, Inc. transdermal gel 1%)
FDA-2013-P-0351 Center for Food Safety Antibiotics in Food-Producing Drug

& Institute for Animals
Agriculture and Trade
Policy
FDA-2013-P-0337 Hyman, Phelps & Warning Letter Publication Stay Drug
McNamara, P.C.
FDA-2013-P-0336 Emcure BENADRYL (diphenhydramine Drug

Pharmaceuticals USA HCl) Injection, 50 mg /mL
Inc.
FDA-2013-P-0335 Foley & Lardner LLP NILANDRON (nilutamide) Drug

Tablets
FDA-2013-P-0323 Rapid Precision Testing OTC Sunscreens Drug

Laboratories
FDA-2013-P-0303 Tedor Pharma Inc. METADATE ER Drug

(methylpheindate HCl)
FDA-2013-P-0299 Trigen Laboratories Bisoprolol Fumarate Tablets Drug

(BioKey, Inc.)
FDA-2013-P-0298 Yale University Metformin Drug
FDA-2013-P-0291 Fukushima Fallout Cesium 134 and Cesium 137 Foods,

Awareness Network contamination Dietary
(Citizens for Health) Supps, and
Drugs
FDA-2013-P-0285 New York City Tobacco Products - Track and Tobacco
Department of Health & Trace System Products
Mental Hygiene, et. al.
FDA-2013-P-0283 Hyman, Phelps & C1 Esterase Inhibitor (Human) Drug

McNamara, P.C. Products (CINRYZE and
BERINERT)
FDA-2013-P-0280 R.J. Reynolds Tobacco Tobacco Products - User Fees Tobacco

Company, et. al. Products
FDA-2013-P-0247 Novartis RECLAST (zoledronic acid) Drug

Pharmaceuticals Corp. Injection
FDA-2013-P-0247 Novartis RECLAST (zoledronic acid) Drug
Pharmaceuticals Corp. Injection
FDA-2013-P-0241 Foley & Lardner LLP CYTOXAN Drug

(cyclophosphamide) for
Injection
FDA-2013-P-0235 Wess Eric Sharpe Lantos Technologies' 3D Ear Medical

Scanner Device
FDA-2013-P-0228 Douglas Barasatian Bleached White Flour GRAS Food

Status
FDA-2013-P-0219 International Isotopes, HICON Kit for the Preparation Drug

Inc. of Sodium Iodide 1131
Capsules and Solution
FDA-2013-P-0217 Center for Science in Added Sugars/High-Fructose Food

the Public Interest Corn Syrup
FDA-2013-P-0203 Merchant & Gould P.C. VFEND IV (voriconazole) for Drug

Injection
FDA-2013-P-0198 Takeda DEXILANT (dexlansoprazole) Drug

Pharmaceuticals delayed-release capsules
U.S.A., Inc.
FDA-2013-P-0204 Square GDUFA User Fees Drug

Pharmaceuticals Ltd
(Chrai Associates, Inc.)
FDA-2013-P-0199 Richard M. Karcich Software Validation Medical

Device
FDA-2013-P-0170 Clinipace Worldwide PLAQUENIL Drug

(hydroxychloroquine sulfate
tablet) 200 mg
FDA-2013-P-0163 Teva Pharmaceutical PARAGARD T 380A Drug

Industries Ltd. Intrauterine Copper
Contraceptive
FDA-2013-P-0148 Crowell & Moring LLP. LOVAZA (omega-3-acid ethyl Drug

esters) Capsules
FDA-2013-P-0127 Santarus, Inc. UCERIS (budesonide) Drug


FDA-2013-P-0113 IGI Laboratories Inc. CORDRAN (flurandrenolide) Drug

Ointment USP, 0.05%
FDA-2013-P-0076 Minnesota Medical 510(k) Process Medical

Device Alliance Device
FDA-2013-P-0070 Ikaria, Inc. 510(k) Clearance of GeNOsy1 Medical

MV-1000 Device
FDA-2013-P-0066 Pharmacists Planning St John's Wort (hypericum Dietary

Services, Inc. perforatum) Supplement
FDA-2013-P-0058 Gilead Sciences, Inc. STRIBILD (elvitegravir, Drug

cobicistat, emtricitabine,
tenofovir disoproxil fumarate)
Tablets
FDA-2013-P-0048 James P Reichmann ZOFRAN (ondansetron) Drug
FDA-2013-P-0047 American Heart Raw fruits & vegetables; Food

Association Single-ingredient or mixtures of
frozen or canned fruits and
vegetables
FDA-2013-P-0040 Lupin Pharmaceuticals, PHOSLO (calcium acetate) Drug

Inc. Capsules
FDA-2013-P-0028 Custo Pharm Inc. Clotrimazole Troche/Lozenge Drug
FDA-2013-P-0027 Custo Pharm Inc. Midodrine HCl Tablets Drug
FDA-2013-P-0025 Teva Pharmaceutical Approval of Multiple Sclerosis Drug

Industries Ltd. Drugs
Petition Tracker


Discontinuation

Denied in part

ANDA Suitability
Petition


Discontinuation
Denied in part


Discontinuation
Discontinuation
ANADA Suitability
Petition
ANADA Suitability
Petition
Discontinuation


(505(q) Certification Denied in part



Discontinuation


ANDA Suitability
Petition


Denied in part

Petition for Stay

Petition for Stay



ANDA Suitability
Petition
ANDA Suitability
Petition
Discontinuation


ANDA Suitability
Petition
ANADA Suitability
Petition
Petition for Stay and 2/8/2017

Reconsideration

ANADA Suitability
Petition
ANDA Suitability
Petition
Citizen Petition - PTE 8/21/2013 Pending

Due Diligence

Discontinuation
ANDA Suitability
Petition


ANADA Suitability
Petition
Petition for 4/8/2014 8/28/2014 Interim response

Reconsideration

Discontinuation
Designation

ANDA Suitability
Petition
ANDA Suitability
Petition

Discontinuation


Designation

Designation

ANDA Suitability
Petition

ANDA Suitability
Petition
ANDA Suitability
Petition

ANDA Suitability
Petition

Discontinuation
ANDA Suitability
Petition
Discontinuation
ANDA Suitability
Petition

Health Claim Petition

Denied in part
Petition for 7/4/2014 1/19/2017 Granted in part;

Reconsideration Denied in part


Designation

ANDA Suitability
Petition
Discontinuation
Designation

ANDA Suitability
Petition
Discontinuation
Citizen Petition - 5/24/2013 7/18/2013 Approved

ANADA Suitability
Petition
Discontinuation



Discontinuation


Denied in part

ANDA Suitability
Petition

ANDA Suitability
Petition

Designation

Discontinuation

Designation
Petition for 4/19/2013 8/1/2014 Withdrawn

Reconsideration



ANADA Suitability
Petition


Designation

Citizen Petition 3/26/2013
2/9/2015 Granted in part;

Denied in part
Petition for Stay of 3/19/2013 3/28/2013 Withdrawn

Action

Listed Drug
Discontinuation

Discontinuation

Designation

Denied in part
Citizen Petition - 5/4/2016

Petition for
Reconsideration

Petition for 8/23/2013 12/4/2013 Denied
Reconsideration

Discontinuation

ANDA Suitabiity
Petition


ANDA Suitability
Petition


Reconsideration/Petit
ion for STay (505(q)
Certification)

Discontinuation
Petition for Stay of 1/2/2013 7/25/2013 Denied

Action

Denied in part

Reconsideration

Health Claim Petition

Second RLD
Designation

Second RLD
Designation
Designation

FDA-2012-P-1091 Valeant WELLBUTRIN XL (bupropion Drug

Pharmaceuticals HCl) Extended-release Tablets,
International, Inc. 300 mg
FDA-2012-P-1087 Warner Chilcott ASACOL/ASACOL HD Drug
Company, LLC (mesalamine) Delayed-release
Tablets
FDA-2012-P-1072 Boehringer Ingelheim SPIRIVA HandiHaler Drug
Pharma, Inc. (tiotropium bromide inhalation
powder)
FDA-2012-P-1028 Reckitt Benckiser SUBUTEX (buprenorphine Drug

Pharmaceuticals, Inc. HCl) &
SUBOXONE(buprenorphine
HCl; naloxone HCl)
FDA-2012-P-1018 Mutual Pharmaceutical COLCRYS (colchicine) Tablets Drug

Company, Inc.
FDA-2012-P-1009 Pfizer Inc. OXECTA (oxycodone HCl) Drug

Tablets
FDA-2012-P-0951 Endo Pharmaceuticals, OPANA ER (oxymorphone Drug

Inc. HCI) Extended-release Tablets
FDA-2012-P-0947 Mallinckrodt Inc. EXALGO (Hydromorphone Drug

HCl) Extended-release Tablets
FDA-2012-P-0943 Sunovion LUNESTA (eszopiclone) Drug

Pharmaceuticals, Inc Tablets
FDA-2012-P-0939 Purdue Pharma L.P. OxyContin (oxycodone Drug

hydrochloride) Controlled-
Release Tablets
FDA-2012-P-0932 Noven DAYTRANA (methylphenidate) Drug

Pharmaceuticals, Inc. Transdermal System
FDA-2012-P-0915 Sunovion LUNESTA (eszopiclone) Drug

Pharmaceuticals, Inc Tablets
FDA-2012-P-0895 Endo Pharmaceuticals, OPANA ER (oxymorphone Drug
Inc. HCI) Extended-release Tablets
FDA-2012-P-0779 Valeant ZOVIRAX (acyclovir) Ointment Drug

Pharmaceuticals 5%
International, Inc.
FDA-2012-P-0764 The Joseph Dedvukaj QSYMIA (phentermine and Drug

Firm, P.C. topiramate extended-release)
Capsules
FDA-2012-P-0760 Purdue Pharma L.P. OxyContin (oxycodone Drug

hydrochloride) Controlled-
Release Tablets
FDA-2012-P-0749 Merck Sharp & Dohme NASONEX (mometasone Drug

Corp. furoate monohyrdrate)
FDA-2012-P-0733 Jazz Pharmaceuticals, XYREM (sodium oxybate) Oral Drug

Inc. Solution
FDA-2012-P-0647 Laboratorios SALVAT CETRAXAL (ciprofloxacin HCl) Drug

SA
FDA-2012-P-0637 KV Pharmaceutical Hydroxyprogesterone Caproate Drug

Company Injection
FDA-2012-P-0607 AIDS Healthcare TRUVADA (emtricitabine and Drug

Foundation tenofovir disoproxil fumarate)
FDA-2012-P-0583 Pfizer, Inc. LYRICA (pregabalin) Drug

Acetate) Injection
FDA-2012-P-0549 Anatase ROCALTROL (calcitriol) Drug

Biopharmaceutic Capsules, 0.25 microgram and
Consulting LLC 0.5 microgram
FDA-2012-P-0545 Pfizer, Inc. LYRICA (pregabalin) Drug

Pharmaceutical Corp. Release Tablets
FDA-2012-P-0507 Cumberland ACETADOTE (acetyl cysteine Drug

Pharmaceuticals Inc. injection)
FDA-2012-P-0499 Jazz Pharmaceuticals, XYREM (sodium oxybate) Oral Drug

Inc. Solution
FDA-2012-P-0412 Anatase ROCALTROL (calcitriol) Drug
Biopharmaceutic Capsules, 0.25 microgram and
Consulting LLC 0.5 microgram
FDA-2012-P-0295 Janssen ELMIRON (pentosan Drug

Pharmaceuticals, Inc. polysulfate sodium)
FDA-2012-P-0189 Lannett Company, Inc. Ocycodone HCl and Cocaine Drug

and Cody Laboratories, HCl (Grandfather status)
Inc.
FDA-2012-P-0184 Fresenius Medical Care PhosLo (calcium acetate) Drug

North America
FDA-2012-P-0053 Lannett Company, Inc. Morphine Sulfate (Grandfather Drug

and Cody Laboratories, status)
Inc.
Petition Tracker


Citizen Petition 10/17/2012 4/15/2013 Interim response;

(505(q) Certification) FDA does not
consider this a 505(q)
petition







Reconsideration


(505(q) Certification) (resubmitted as FDA-
2012-P-0943)
Citizen Petition 8/13/2012 2/8/2013 Interim response;
(505(q) Certification) FDA does not
Listed Drug consider this a 505(q)
Discontinuation petition
5/10/2013 Denied


Citizen Petition 7/16/2012 10/3/2012 Closed (resubmitted

(505(q) Certification) as FDA-2012-P-
0939)




Citizen Petition 6/8/2012 7/16/2012 Denied (Not

(505(q) Certification) considered a 505(q)
petition)




(505(q) Certification) (Resubmitted as
FDA-2012-P-0583)



(505(q) Certification) (Resubmitted as
FDA-2012-P-0549)

Citizen Petition 2/24/2012 7/5/2012 Denied (Ocycodone

(505(q) Certification) HCl)
11/12/2015 Denied (Cocaine

HCl)


FDA-2011-P-0931 Upsher-Smith Extended-release Topiramate Drug

Laboratories, Inc.
FDA-2011-P-0840 Perrigo Company Prevacid®24HR (lansoprazole) Drug

Capsules
FDA-2011-P-0823 AstraZeneca CRESTOR (rosuvastatin Drug

Pharmaceuticals LP calcium) Tablets
FDA-2011-P-0767 Somaxon SILENOR (doxepin) Drug

FDA-2011-P-0702 Warner Chilcott, LLC & DORYX (doxycycline hyclate) Drug

Mayne Pharmaceuticals Delayed-Release Tablet, 150
International Pty Ltd. mg
FDA-2011-P-0663 AstraZeneca SEROQUEL XR (quetiapine Drug

Pharmaceuticals LP fumarate) Extended-release
Tablets
FDA-2011-P-0662 AstraZeneca SEROQUEL (quetiapine Drug

Pharmaceuticals LP fumarate) Tablets
FDA-2011-P-0654 Acorda Therapeutics, ZANAFLEX (tizanidine HCl) Drug

Inc. Capsules
FDA-2011-P-0610 Abbott Laboratories ANDROGEL (testosterone gel) Drug
FDA-2011-P-0593 LEO Pharma, Inc. DOVONEX Cream Drug

(calcipotriene 0.005%)
FDA-2011-P-0575 Warner Chilcott ASACOL (mesalamine) Drug

Company, LLC Delayed-Release Tablets
FDA-2011-P-0565 LEO Pharma, Inc. TACLONEX Ointment & Scalp Drug

(calcipotriene 0.005% and
betamethasone dipropionate
0.064%)
FDA-2011-P-0482 Novo Nordisk VAGIFEM (estradiol vaginal Drug

tablets)
tablets)
FDA-2011-P-0450 MSMB Capital LYMPHOSEEK Drug

Management LLC
FDA-2011-P-0433 Lehigh Valley Oxycodone HCl Drug

Technologies, Inc. &
Glenmark Generics,
Inc. USA
FDA-2011-P-0227 Intendis, Inc. FINACEA (azelaic acid) Gel, Drug

15%
FDA-2011-P-0128 ISTA Pharmaceuticals, BROMDAY/XIBROM Drug

Inc. (bromfenac ophthalmic
solution)
FDA-2011-P-0127 Baxter Healthcare SA SUPRANE (desflurane) Drug
FDA-2011-P-0120 Pronova LOVAZA (omega-3-acid ethyl Drug

esters)
FDA-2011-P-0087 Navinta LLC VENOFER (iron sucrose) Drug
FDA-2011-P-0086 Johnson & Johnson RISPERDAL CONSTA Drug

Pharmaceutical (risperidone) LONG-ACTING
Research, LLC INJECTION
FDA-2011-P-0072 Navinta LLC VENOFER (iron sucrose) Drug
FDA-2011-P-0045 Purdue Pharma L.P. REMOXY (oxycodone) Drug

Controlled-release Capsules
Petition Tracker












Citizen Petition 6/17/2011 12/12/2011 Pending; FDA does

(505(q) Certification) not consider this a
505(q) petition
Citizen Petition

Denied in part

505(q) petition


505(q) petition
Denied in part




Citizen Petition 2/10/2011 Pending; FDA does

505(q) petition
Citizen Petition 2/8/2011 Withdrawn
2011-P-0087)

FDA-2010-P-0648 G. Pohl-Boskamp NITROLINGUAL PUMPSTRAY Drug

GmbH & Company KG (nitroglycerin lingual spray)

Acetate) Injection
FDA-2010-P-0625 ISTA Pharmaceuticals, XIBROM (bromfenac Drug

Inc. ophthalmic solution)
FDA-2010-P-0624 Cubist CUBCIN (daptomycin for Drug

Pharmaceuticals, Inc. injection)
FDA-2010-P-0614 Mutual Pharmaceutical COLCRYS (colchicine) Tablets Drug

Company, Inc.
FDA-2010-P-0613 Watson Laboratories, ANDRODERM (testosterone Drug

Inc. transdermal system)
FDA-2010-P-0574 Beckloff Associates FAZACLO (clozapine) Orally Drug

Disintegrating Tablets
FDA-2010-P-0570 Nycomed US, Inc. CUTIVATE (fluticasone Drug

propionate) Lotion
FDA-2010-P-0561 Lupin Atlantis Holdings, ANTARA (fenofibrate) Drug

S.A. Capsules
FDA-2010-P-0549 Lupin Ltd. COMBIVIR (lamivudine; Drug
zidovudine) Tablets,
150mg/300 mg
FDA-2010-P-0546 Beckloff Associates FAZACLO (clozapine) Orally Drug

Disintegrating Tablets
FDA-2010-P-0545 UCB, Inc. XYZAL (levocetirizine Drug

dihydrochloride)
FDA-2010-P-0531 Peptimmune, Inc. COPAXONE (Glatiramer Drug

Acetate) Injection
FDA-2010-P-0518 Hoffmann-La Roche, BONIVA (ibandronate sodium) Drug

Inc. Once-Monthly
FDA-2010-P-0438 Dr. Reddy's FOSAMAX PLUS D Drug

(alendronate sodium;
cholecalciferol) Tablets; MaPP
5240.3
FDA-2010-P-0430 Eisai, Inc. ARICEPT (donepezil HCl) Drug

tablets)
FDA-2010-P-0396 Cephalon, Inc. FENTORA (fentanyl) Buccal Drug

Tablets
FDA-2010-P-0383 Cephalon, Inc. FENTORA (fentanyl) Buccal Drug

Tablets
FDA-2010-P-0317 Teva Neuroscience Albuterol Sulfate HFA Drug

Inhalation Aerosol Drug
Products
FDA-2010-P-0309 Shire Development Inc. FOSRENOL (lanthanum Drug

carbonate) Chewable Tablets

FDA-2010-P-0243 Endo Phannaceuticals OPANA (oxymorphone HCl) Drug

Inc. Tablets & OPANA
(oxymorphone HCl) Extended-
Release Tablets
FDA-2010-P-0223 Genzyme Corp. HECTOROL (doxercalciferol) Drug

Injection
FDA-2010-P-0216 Flamel Technologies COREG CR (carvedilol Drug
S.A. phosphate) Extended-release
Capsules
FDA-2010-P-0196 Abbott Laboratories ANDROGEL (testosterone gel) Drug
FDA-2010-P-0188 Actavis Elizabeth LLC ADDERALL XR (amphetamine Drug

combination extended-release
capsules)
FDA-2010-P-0111 Warner Chilcott ASACOL (mesalamine) Drug

Company, LLC Delayed-Release Tablets
FDA-2010-P-0092 Lupin Atlantis Holdings, ANTARA (fenofibrate) Drug

S.A. Capsules
FDA-2010-P-0087 Sandoz, Inc. LYRICA (Pregabalin) Capsules Drug
FDA-2010-P-0082 Actavis Elizabeth, LLC KADIAN (morphine sulfate) Drug

Extended-Release Capsules
FDA-2010-P-0069 Kremers Urban, LLC Highly Potent Pharmaceutical Drug

Products
FDA-2010-P-0017 Kremers Urban, LLC Highly Potent Pharmaceutical Drug

Products
Petition Tracker
Citizen Petition 12/21/2010 6/16/2011 Pending; FDA interim

(505(q) Certification) response indicates
not a 505(q) petition

Denied in part
Citizen Petiton 10/7/2012 10/31/2013 Granted in part;

(Petition for Stay) Denied in part








5/25/2011 Denied





4/8/2011 Withdrawn




Citizen Petition 6/16/2010 12/8/2015 Withrawn







6/21/2012 Withdrawn


Reconsderation





FDA-2009-P-0601 Navinta LLC NAROPIN (ropivacaine HCl Drug

monohydrate) Injection
FDA-2009-P-0597 GlaxoSmithKline Inhalation Products Containing Drug

Fluticasone Propionate and/or
Salmeterol Xinafoate
FDA-2009-P-0580 Arent Fox Articaine Drug
FDA-2009-P-0578 Dey Pharma, L.P. EPIPEN (epinephrine) Auto- Drug

Injector

Acetate) Injection
FDA-2009-P-0522 Lupin Pharmaceuticals, SUPRAX (cefixime) Oral Drug

Inc. Suspension
FDA-2009-P-0446 Virginia Commonwealth Buprenorphine HCl Drug

University
FDA-2009-P-0423 Graceway ALDARA (imiquimod) Cream Drug

Pharmaceuticals
FDA-2009-P-0415 Mylan Inc. DURAGESIC (fentanyl) Drug
FDA-2009-P-0411 Sandoz Inc. ACTOS (pioglitazone HCl) Drug

Tablets & ACTOPLUS MET
(pioglitazone HCl; metformin
HCl) Tablets

FDA-2009-P-0398 Pronova LOVAZA (omega-3-acid ethyl Drug

esters)
FDA-2009-P-0379 Mallinckrodt, Inc. Tyco RESTORIL (temazepam) Drug

Healthcare Group LP Capsules
FDA-2009-P-0364 Graceway ALDARA (imiquimod) Cream Drug

Pharmaceuticals
FDA-2009-P-0334 Reckitt Benckiser MUCINEX (guaifenesin) Drug

Group plc products
FDA-2009-P-0326 Apotex Inc. ARICEPT (donepezil) Drug
FDA-2009-P-0325 Reckitt Benckiser SUBUTEX (buprenorphine) Drug

Pharmaceuticals, Inc. and SUBOXONE
(buprenorphine; naloxone)
FDA-2009-P-0289 Reckitt Benckiser SUBUTEX (buprenorphine) Drug

Pharmaceuticals Inc. and SUBOXONE
FDA-2009-P-0272 Sanofi-aventis TAXOTERE (docetaxel) Drug

Injection
FDA-2009-P-0266 Dr. Reddy's REMS and Biostudy Sample Drug
FDA-2009-P-0265 Galderma DIFFERIN (adapalene) Drug
FDA-2009-P-0225 Galderma ORACEA (doxycline) Drug
FDA-2009-P-0223 URL Mutual SKELAXIN (metaxalone) Drug

Tablets
FDA-2009-P-0216 Ortho-Biotech Products, DOXIL (doxorubicin HCl) Drug

Liposome Injection
FDA-2009-P-0183 Procter & Gamble OTC Proton Pump Inhibitors Drug
FDA-2009-P-0154 UNC Gillings School of SUBUTEX (buprenorphine) Drug

Global Public Health and SUBOXONE
FDA-2009-P-0123 TESTIM (testosterone Drug
Auxilium Pharm., Inc.
transdermal gel, 1%)
FDA-2009-P-0120 Stiefel Laboratories, EVOCLIN (clindamycon Drug
Inc. phosphate)
FDA-2009-P-0115 Mitsuishi / Oblan Spivak Argatroban Drug Substance Drug

tablets)
FDA-2009-P-0103 The Roche Group CELLCEPT (mycophenolate Drug

mofetil)
FDA-2009-P-0081 Medicis (Hunton & SOLODYN (minocycline HCl) Drug

Williams)
FDA-2009-P-0059 Eurand Porcine-Derived Pancreatic Drug

Enzyme Product
FDA-2009-P-0042 Mitsuishi / Oblan Spivak Argatroban Drug Substance Drug
FDA-2009-P-0038 Mayne Pharma & DORYX (doxycycline hyclate) Drug

Warner Chilcott
FDA-2009-P-0040 King Pharm. Sumatriptan Succinate Drug

Injection
Petition Tracker









Citizen Petition 8/25/2009 3/15/2010 Granted (Not

(505(q) Certification) considered by FDA to
be a 505(q) citizen
petition)







Denied in part





Denied in part





Denied in part




Citizen Petition 2/18/2009 8/14/2009

Pending; FDA interim
response indicates
Denied in part




2009-P-0115)


FDA-2008-P-0654 Procter & Gamble OTC Omeprazole/Sodium Drug

Bicarbonate
FDA-2008-P-0621 EKR Therapeutics Nicardipine HCl Injection Drug
FDA-2008-P-0625 Ista Pharm. Topical Opthalmic Rx Drug Drug

Products
FDA-2008-P-0616 Upsher-Smith Salmon-Calcitonin (Synthetic Drug

or Recombinant)
FDA-2008-P-0599 Procter & Gamble OTC Omeprazole/Sodium Drug

Bicarbonate
FDA-2008-P-0586 Mayne Pharma Intl. & Doxycycline Hyclate Relayed- Drug

Warner Chilcott Release Tablets
FDA-2008-P-0587 Warner Chillcot Norethrindrone acetate/ethinyl Drug

estradiol/ferrous fumerate

Acetate) Injection
FDA-2008-P-0532 Shire Pharm. Carbamazepine Drug
FDA-2008-P-0524 Luitpold Pharm. Ferumoxytol Drug
FDA-2008-P-0507 Shire Pharm. Mesalamine Drug

FDA-2008-P-0441 Warner Chilcott Norethrindrone acetate/ethinyl Drug
estradiol/ferrous fumerate
FDA-2008-P-0442 Mutual Pharm. Colchicine Indicated for Drug

Prophylaxis of Gouty Flare
FDA-2008-P-0411 Caraco Pharm. Labs., PRANDIN (repaglinide) Drug

Ltd.
FDA-2008-P-0374 Mayne Pharm. Intl. & Doxycycline Hyclate Drug

Warner Chilcott
FDA-2008-P-0366 Purdue Pharm. Oxycodone Drug
FDA-2008-P-0365 ISTA Pharm. Various Drugs (imported API) Drug
FDA-2008-P-0368 ISTA Pharm. Bromfenac Sodium Ophthalmic Drug

Solution
FDA-2008-P-0343 Novo Nordisk PRANDIN (repaglinide) Drug
FDA-2008-P-0329 Osmotica Pharm. Venlafaxine HCl Extended- Drug

Release Tablets
FDA-2008-P-0318 Mylan Pharm. Nisoldipine Drug
FDA-2008-P-0304 King Pharm. Ramipril Drug
FDA-2008-P-0300 Salix Pharm Rifaximin Drug
FDA-2008-P-0236 Altus Pharm. Pancreatin/Pancrealipase Drug

FDA-2008-P-0250 Altus Pharm. Pancreatin/Pancrealipase Drug
FDA-2008-P-0185 Medicis Pharm. Corp. Minocycline HCl Drug
FDA-2008-P-0187 Ferring B.V. Pancreatin/Pancrealipase Drug
FDA-2008-P-0122 Bristol Myers Squibb Technetium TC-99M Seseamibi Drug
FDA-2008-P-0117 Apotex Clopidogrel Bisulfate Drug
FDA-2008-P-0126 Olson & Cepuritis, Ltd. Pancreatin/Pancrealipase Drug

(Ferring B.V.)
FDA-2008-P-0069 Watson Labs Irinotecan HCl Drug
FDA-2008-P-0052 Mutual Pharm. Co. Metaxalone Drug

Petition Tracker



Petition for 7/1/2009 Pending

Reconsideration


2008-P-0654)





6/30/2009 Denied


Denied in part
Reconsideration
Citizen Petition 8/5/2008 11/20/2008 Withdrawn;

(505(q) Certification) Resubmitted as FDA-
2008-P-0587
Citizen Petition 8/4/2008 10/8/2009 Withdrawn; FDA
(505(q) Certification) interim response
indicates not a 505(q)
petition
Amended Citizen 7/22/2008 12/4/2008 Granted

Petition





Denied in part

Petition for Stay of 12/20/2008 6/16/2009 Denied as Moot

Action
Petition for 12/19/2008 6/16/2009 Denied as Moot

Reconsideration



Citizen Petition 5/14/2008 11/10/2008

(505(q) Certification) Pending; FDA interim
response indicates
(505(q) Certification) Denied in part.



Citizen Petition 2/13/2008 5/17/2012 Denied (Not a FDC

(505(q) Certification) Act 505(q) petition)
Citizen Petition 2/19/2008 9/10/2008 Closed. Reopened

(505(q) Certification) as FDA-2008-P-
0187.

FDA-2007-P-0235 Mutual Pharm. Co. Felodipine Extended-Release Drug

Tablets USP
FDA-2007-P-0123 Mutual Pharm. Co. Felodipine Extended-Release Drug

Tablets
FDA-2007-P-0418 Cobalt Acarbose Drug
FDA-2007-P-0183 Purdue Pharm. Oxycodone HCl Drug
FDA-2007-P-0169 Unimed Dronabinol Drug

Petition Tracker



Petition for Stay of 11/9/2007 5/7/2008 Denied.

Action
Petition for Stay of 10/15/2007 3/24/2008 Denied

Action (505(q)
Certification)
Peition for 4/1/2008 Pending (no

Reconsideration certification included;
probably not a FDC
Act 505(q) petition)


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FDA Citizen Petition Tracker

Docket No. Petitioner Product Name/Issue Category

FDA-2017-P-1108 Orbicular TIMOPTIC (Timolol Maleate) Drug

FDA-2017-P-1096 Hyman, Phelps & VASOSTRICT (vasopressin) Drug

FDA-2017-P-1039 Beck & Thomas Potassium Chloride Oral Drug Drug

FDA-2017-P-1002 Inrange Systems, Inc. Product Detention Medical

FDA-2017-P-0970 RiceBran Technologies Rice Bran/Rice Fiber Food

FDA-2017-P-0868 David Wong Quetiapine Fumerate Drug

FDA-2017-P-0866 Hyman Phelps & THIOPLEX (thiotepa) for Drug

FDA-2017-P-0864 Hyman Phelps & Ibuprofen Tablets, 200 mg Drug

FDA-2017-P-0863 Fresenius Kabi USA, Sodium Chloride 23.4% Drug

FDA-2017-P-0757 Vertice Pharma, Inc. Potassium Chloride Oral Drug Drug

FDA-2017-P-0662 Impax Laboratories, Inc. RYTARY (carbidopa and Drug

FDA-2017-P-0495 Lachman Consultant CORDARONE (amiodarone Drug

FDA-2017-P-0494 Navinta LLC Sodium Phenylacetate and Drug

FDA-2017-P-0398 Florek & Endres PLLC Hydromorphone HCl Extended- Drug

FDA-2017-P-0290 Malaysian Rubber Powdered Gloves Medical

FDA-2017-P-0137 Macleods Pyrazinamide Tablets 500 mg Drug

Petition Type Receipt Date Decision Date Decision

Citizen Petition - 2/22/2017 Pending

Citizen Petition - 2/17/2017 Pending

Citizen Petition 2/13/2017 Pending

Citizen Petition 2/13/2017 Pending

Citizen Petition 2/8/2017 Pending

Citizen Petition 2/8/2017 Pending

Citizen Petition - 2/8/2017 Pending

Citizen Petition - 2/8/2017 Pending

Citizen Petition 1/31/2017 Pending

Citizen Petition 1/25/2017 Pending

Citizen Petition - 1/25/2017 Pending

Citizen Petition - 1/18/2017 Pending

Citizen Petition 1/9/2017 Pending

Citizen Petition - RLD 1/9/2017 Pending

Citizen Petition - 1/5/2017 Pending

FDA-2016-P-4587 Mallinckrodt INOmax (nitric oxide) Drug

FDA-2016-P-4585 Acorda Therapeutics, AMPYRA (dalfampridine) Drug

FDA-2016-P-4584 Public Citizen Health Repaglinide-containing Drug

FDA-2016-P-4341 Osmotica Venlafaxine HCl Extended- Drug

FDA-2016-P-4275 BioNeutra North Dietary Fibers - Isomalto- Food

FDA-2016-P-4274 Teligent, Inc. Mupirocin Ointment 2% Drug

FDA-2016-P-4233 KFSU Ltd. Sugarcane Flour Food

FDA-2016-P-4186 Lachman Consultant CALCIMAR (calcitonin salmon) Drug

FDA-2016-P-4164 Lachman Consultant Carbinoxamine Maleate Orally Drug

FDA-2016-P-4094 Adapt Pharma Intranasal Naloxone Drug

FDA-2016-P-4047 Mayne Pharma DORYX MPC (doxycycline Drug

FDA-2016-P-3912 Adapt Pharma NARCAN (naloxone) Nasal Drug

FDA-2016-P-3823 Jennifer A. Osler TBD TBD

FDA-2016-P-3753 MacLeods Diclofenac Sodium Topical Drug

FDA-2016-P-3674 Consumers for Dental Dental Amalgum Drug

FDA-2016-P-3620 MGP Ingredients, Inc. Modified Wheat Starch Food

FDA-2016-P-3510 Zhuhai Kinhoo Cefadroxil Chewable Tablets Drug

FDA-2016-P-3465 Novitium Pharma LLC Ranitidine Capsules, 150 mg Drug

FDA-2016-P-3463 Axinn, Veltrop & Apixaban Tablets, 10 mg Drug

FDA-2016-P-3428 Felix Pharmaceuticals Cefpodoxime Proxetil Animal Drug

FDA-2016-P-3426 Novitium Pharma LLC Minipress Capsules, EQ 2mg Drug

FDA-2016-P-3418 Salix Pharmaceuticals, XIFAXAN (rifaximin) Tablets Drug

FDA-2016-P-3356 Sandoz Inc. ADVAIR DISKUS100/50 Drug

FDA-2016-P-3313 Purdue Pharma L.P. BUTRANS (buprenorphine) Drug

FDA-2016-P-3312 Gilead Sciences, Inc. STRIBILD (elvitegravir, Drug

FDA-2016-P-3311 Tate & Lyle Ingredients Polydextrose Food

FDA-2016-P-3112 Mario Morais Citizen Petition Response Misc

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