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    The document contains information about approved drug products containing the active ingredient meclizine hydrochloride. It lists the proprietary and non-proprietary names, application numbers, dosage forms, strengths, and approval details for various drug products. There are multiple generic drug approvals for tablets and chewable tablets containing 12.5 mg, 25 mg, and 50 mg of meclizine hydrochloride.

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    The document contains information about approved drug products containing the active ingredient meclizine hydrochloride. It lists the proprietary and non-proprietary names, application numbers, dosage forms, strengths, and approval details for various drug products. There are multiple generic drug approvals for tablets and chewable tablets containing 12.5 mg, 25 mg, and 50 mg of meclizine hydrochloride.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as xlsx, pdf, or txt
    10 views3 pages

    Meclizine Orange Book Information

    Uploaded by

    katyayani9
    The document contains information about approved drug products containing the active ingredient meclizine hydrochloride. It lists the proprietary and non-proprietary names, application numbers, dosage forms, strengths, and approval details for various drug products. There are multiple generic drug approvals for tablets and chewable tablets containing 12.5 mg, 25 mg, and 50 mg of meclizine hydrochloride.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as xlsx, pdf, or txt
    of 3

    Orange Bo

    Mkt.Status Active Ingredient Proprietary Name Appl. No.


    RX MECLIZINE HYDROCHLORIDE ANTIVERT N010721
    RX MECLIZINE HYDROCHLORIDE ANTIVERT N010721
    RX MECLIZINE HYDROCHLORIDE ANTIVERT N010721
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A201451
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A087127
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A200294
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A205136
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A040659
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A202640
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A084843
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A201451
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A087128
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A200294
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A205136
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A084092
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A040659
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A202640
    RX MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A205136
    RX MECLIZINE HYDROCHLORIDE ANTIVERT N010721
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A085253
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A085269
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A088732
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A084657
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A084382
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A083784
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A085524
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A040179
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A089113
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A088256
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A087877
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A085195
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A085252
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A085891
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A084657
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A085740
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A084872
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A085523
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A088734
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A040179
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A089114
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A088257
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A087620
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A201451
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A202640
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A089674
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A084976
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A086392
    DISCN MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE A088733
    Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
    Product Number Dosage Form Route Strength TE Code RLD RS
    006 TABLET ORAL 12.5MG AA RLD
    004 TABLET ORAL 25MG AA RLD
    001 TABLET ORAL 50MG AA RLD
    001 TABLET ORAL 12.5MG AA RS
    001 TABLET ORAL 12.5MG AA
    001 TABLET ORAL 12.5MG AA
    001 TABLET ORAL 12.5MG AA
    001 TABLET ORAL 12.5MG AA
    001 TABLET ORAL 12.5MG AA
    002 TABLET ORAL 12.5MG AA
    002 TABLET ORAL 25MG AA RS
    001 TABLET ORAL 25MG AA
    002 TABLET ORAL 25MG AA
    002 TABLET ORAL 25MG AA
    003 TABLET ORAL 25MG AA
    002 TABLET ORAL 25MG AA
    002 TABLET ORAL 25MG AA
    003 TABLET ORAL 50MG
    005 TABLET, CHEWABLE ORAL 25MG AA RLD
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    002 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 12.5MG
    001 TABLET ORAL 25MG
    001 TABLET ORAL 25MG
    001 TABLET ORAL 25MG
    001 TABLET ORAL 25MG
    001 TABLET ORAL 25MG
    001 TABLET ORAL 25MG
    001 TABLET ORAL 25MG
    002 TABLET ORAL 25MG
    001 TABLET ORAL 25MG
    001 TABLET ORAL 25MG
    001 TABLET ORAL 25MG
    003 TABLET ORAL 50MG
    003 TABLET ORAL 50MG
    001 TABLET ORAL 50MG
    001 TABLET, CHEWABLE ORAL 25MG
    001 TABLET, CHEWABLE ORAL 25MG
    001 TABLET, CHEWABLE ORAL 25MG
    luations
    Applicant Holder Approval Date
    CASPER PHARMA LLC Approved Prior to Jan 1, 1982
    CASPER PHARMA LLC Approved Prior to Jan 1, 1982
    CASPER PHARMA LLC Jan 20, 1982
    AMNEAL PHARMACEUTICALS OF NEW YORK LLC Feb 23, 2011
    AUREX LABORATORIES LTD LIABILITY CO Approved Prior to Jan 1, 1982
    EPIC PHARMA LLC Apr 13, 2012
    INDICUS PHARMA LLC Feb 22, 2019
    JUBILANT CADISTA PHARMACEUTICALS INC Jun 4, 2010
    MYLAN PHARMACEUTICALS INC Sep 17, 2012
    SANDOZ INC May 22, 1989
    AMNEAL PHARMACEUTICALS OF NEW YORK LLC Feb 23, 2011
    AUREX LABORATORIES LTD LIABILITY CO Approved Prior to Jan 1, 1982
    EPIC PHARMA LLC Apr 13, 2012
    INDICUS PHARMA LLC Feb 22, 2019
    INVATECH PHARMA SOLUTIONS LLC May 22, 1989
    JUBILANT CADISTA PHARMACEUTICALS INC Jun 4, 2010
    MYLAN PHARMACEUTICALS INC Sep 17, 2012
    INDICUS PHARMA LLC Feb 22, 2019
    CASPER PHARMA LLC Approved Prior to Jan 1, 1982
    ABC HOLDING CORP Approved Prior to Jan 1, 1982
    ANI PHARMACEUTICALS INC Approved Prior to Jan 1, 1982
    ANI PHARMACEUTICALS INC Dec 11, 1985
    ANI PHARMACEUTICALS INC Approved Prior to Jan 1, 1982
    CM BUNDY CO Approved Prior to Jan 1, 1982
    IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAApproved Prior to Jan 1, 1982
    KV PHARMACEUTICAL CO Approved Prior to Jan 1, 1982
    RISING PHARMA HOLDINGS INC Jan 30, 1997
    SUPERPHARM CORP Aug 20, 1985
    UDL LABORATORIES INC Jun 13, 1983
    VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO Apr 20, 1982
    WATSON LABORATORIES INC Approved Prior to Jan 1, 1982
    ABC HOLDING CORP Approved Prior to Jan 1, 1982
    ANABOLIC INC Approved Prior to Jan 1, 1982
    ANI PHARMACEUTICALS INC Approved Prior to Jan 1, 1982
    ANI PHARMACEUTICALS INC Approved Prior to Jan 1, 1982
    CM BUNDY CO Approved Prior to Jan 1, 1982
    KV PHARMACEUTICAL CO Approved Prior to Jan 1, 1982
    PLIVA INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMAC
    Dec 11, 1985
    RISING PHARMA HOLDINGS INC Jan 30, 1997
    SUPERPHARM CORP Aug 20, 1985
    UDL LABORATORIES INC Jun 13, 1983
    VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO Jan 4, 1982
    AMNEAL PHARMACEUTICALS OF NEW YORK LLC Feb 23, 2011
    MYLAN PHARMACEUTICALS INC Sep 17, 2012
    PAR PHARMACEUTICAL INC Mar 31, 1988
    IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAApproved Prior to Jan 1, 1982
    NEXGEN PHARMA INC Approved Prior to Jan 1, 1982
    PLIVA INC Dec 11, 1985

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