!{*lririr}:t *1 i hr.

: I'ilt liilirltrr:
I )c1l:.tt llttc:tt rtl' I.l*ll !tlt

I.tx)l) .\i\t) Dltti(;,\I)i\lI\Is"l lt.t"l'lt)\

FtIA ll,;!'
{ rrii lJriru. ittjt;rlr:r!{-.'1;j'i}'}tiil{'t t1.,. \i.tl-,tttr-1.1,}tti:tiitlt:1-.;l{ ilr

CERTIFICATE OF PRODUCT REGISTRATION

Pursuanl to 1[e provisit;ns ul'Rcpublic Ac1 (R.A.] Nti.3720 as antcntlcd. knowtl as thc Ftxrds'
Drugs. l)evices ancl L'osmetics Ar-:t. aurl consistr-'nt with R.A. Nn. 66?5, knctrvtt as tlttJ (ietlcrics Act ol
19,1!i. anri tl.A. \io. 9711. othurrvisr known as llre Foad attd Drug Adrr:irtistration .,\tt ul'l{}09. tltr:
product describcd hcrcunder lras hccn fcrunrl tt, e cxiirntt u ith the rcquirctttcnts attd slandards lirr
markctnlg aulhorrzatiun cl'phanrraceutical protluels per exis(ing regulations in lirree as ol'tlalc heren[-

Rrgistration Xunth*r llRP-974t)

(lrnrric \amr ,\scorbic r\ciri
Brand Name l{ o la cee
flosage Strrngth & Form Itlt) rnglS r*1. Syrup t()range Flavur)
Ph:rrnracologit Cattgory V itamin
Clasrifieation ()r er-tlic-("(iurler { {}'l ('} Drug
.\ppror ed Shelt-lifc lrt ntouths
Storage Condit ion Sttire ilt lcnlllcrrlures ll()t rxcecdilrg 30o('
Parkaging 'l"ype III Arrrb*r Class [:]atlle Ssnlcrl with Whitc
Alutninum ('ap x 6{l nrl.. 110 rnl.. rnd l5{l rnl.
( Hox o1' l 's)

llanufscturer Nuvagert llltartnacctrtiua[ ('o., Irrc"

ll? Josc Cruz Street. Ilarrio LJgong. Pasig ('ily

'l'he urarketing autlrorizutrul shall hc lalid until 0? ;lpril 2{}?6 suhjtct to thc
conrlilions listed on thu rcvcrsc sirir. Nn changc irr the t'ormulalinn. lahcllirrg and
comrncrcial prcscntaliorl nl'this product shall trc utade fil ntt-y timc tlurirtg the
ci'fce livity of lhis rcgistralion rvithout priur writtcn approval rtl'this O{'f ir:c.
.l
his nrarkeling authorization is sirh.i cct to su-spenston. clttce llttiun t)r rccall
should artv violation of I{,.A. }'io. 37:0. R.A. No. {r675 lrrl R.A. Np. t)7I I aIld",.tr
regulations issircd lhcrcundcr involvin* Ihc procluut bc con"ll'trittcd.

\\'itness 1{v lland anrl $cal of this office. this I8 illar'20?l-

Bt' Auth$rit)' of the Dire ctor Ceneral

Ilcr FDA Orde r Fio, 2{ll6-0{}5
le,
iw-
,rESr".rsA rovtf#/.
c tttu N,\\', ltPh
llirfctor I\r
Centcr lor Drug lltgulation tnd Rcscarch

Rl.ii \i\l; \ \slrnrrlir i{rlertal

*'il: ffi
'\11()t \. i
itld \l \ltit il
l).\ I 1
Php I r,.l0t
!r'{ir:ll!i
!t llrrr}
f5:5tll
I
f0!I
iA"
l5@;'*m
Ii 1ls i.r)l)l
D.i(' I lr -\. { , {ffiflfi$HH{lffl$illlHtilffi{H$fi1fffl{1ilHf,il1ffi
!n!lfil::fi10]lq
FDA-051 1 798
 Registratien Number llRP-9740

SI} ECIAI. COltiIII'I'IOlri I

Provide{ that nuhing in the registration ul'tlrc product herein granted shall be intr:rpleted or constnted
as an e ndorsement or nipresentadon try FDA. lhat Registrant hns thc riglrt or priTilege to thr usc of'the narne or
blinel si:r regisrererl; Rcgis{rant }rrreby agrees anr} *t-tinns to indrrmnify an*or hald FDA free and harmless
againsr any an,J all thir{-par{y itlaiils on in&ingertturt tlf patent. tradenrark nr intellectual property right arising
lionr the registratir;n *l the product.

Ihis ir suh-tcct to batch ncrttficatir;n.

i Io I it,ir is subjr-^tt to lot relcirsc curlilicatiorr

t_* i J

l*l;l I'hrs is rub;ccr ro conrplianee *,ith the rcquir*ments unqler fDA Circular No" l0ll-004 frrr [lonitor*ri

t_i : I R"1."*. llrlR) drug produuls.

t-'rt Subjeet llr posl-marketing surveillancr ol'the markeling authori?ation h*lder's sti.rct ctl$pliance lo lht:
Ceneric I-alxiing Requirr.,mcnts folk-rrving the applicahh provisirrns r,rf A.{} No. 101(;-tX}fi8 fbrdmg
i.l'j prr:ducts lgr human use and A.{-). }I*. 105 t 1991 lbr veltrinary drug prn{ucts.

il;l Submit a $&tisfactory lSioequivrlencc Str.rtly Report ar Eiowaiver twhichcver is applicrrblc) within tho
validity o{ this CPR in accrtdalce r-v'ith IjI}A Circular No. 2016-019'

.i;l I)ang*r*us Drug - To he prescriber{ by PI}EA S-?

prescriptit'rn lbrnr. It is a hatrit-forming drug.
licensed pra,rtitioner in a I}Oll {yellow}

r--r- Dalgerous Drug - '[^o tre prescribed br* I]DEA 5-2 licc*sed practitioner in a personalizrtl oxfinar3
L l., prescripti*n. It is a habit-lirrnring drug.

i-l ,. ] eoti.nr lnlirnnation l-eatlet - Appropnat* infbnnarit:n firr the consumijrs shall be written in Filipino
I " I andior local clialects. as appropriate.
IL_]_"-_i
t..l'.* I Suh,r',,t a Ccrti{icate oI Co*r! Manularturing Practicr: {CI{P) f*mpiiance of' l'oreign Drug
t , f i lr,lanutacturer{s} rvlthin th* validity +f this CPR in a€cordattce with A.(]" n*o.:013-tl0l: and FDA
L .1
('rrcular No. l()l4-0I6.
' --l
[^l- Rcvicrt ol'the submitted llnequivalerree Study Report cr Biorvaiver" whiehever is applicahle- s]rall h.r
I J ct mplcrctl hv the FD-'\ rvithin the validity o{'this CPR: crrrrespondingly, this CPR shall he r*'oked il'
i I produqt uttcrchangealrility has nqt hren establirhed.
-l
I l, SuUi".t ro sxtisi'actory cr:nrpliance to the posi-apprr)\.al conrnritnrents dctailed in thc lettcr
I^ I o..on panving rhis CPR

Rf,}IARKS:

I'his Certiflcate of Product Registration {CPR} is r*newed to chirnge rsgistration numher frorn
tHRP-010 to IIRP-9740)"

Exluustiun up tc retail lcvel of all existing tnv(rntr'lry *f the previour iabelling malt'rial$ is allc'rvr'd r:nlv unti!
!S UeLI!?t. No tirrther exte*tiion shall be grantcd.