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CENTER FOR DRUG EVALUATION ANDRESEARCH
APPLICATIONNUMBER:
21-918
CHEMISTRY REVIEW(S)
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NDA21-918
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CETRAXALI) (ciproOoxaciD otic solution),.0.2%
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Laboratorios SALVAT, SeA.
DivIsIon ofAad-lafectiYe and Ophtbalmolol)' DruaProducts
MIIt.DJ. Sioau, Pb. D.ONDQAPn-Marketial Assessment DtrisIOD D BraJIch IV
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Table of Contents
Table oIC · ,I , 11 1.•.• ' •.• ,111 2·
c~ RevIew DatIl Slaeet.••••••••.lil •••••••••.•••••••••••••• 'i.~•••_ 3
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0'1. AcIIn _••••••_ _••_•••••••••.__._•••••••••••••••••••_•••••••••••••••••••__•••10A. Itevii ·sSf_.1 I~_ ••.••••••...- III.I I _ ' __ _ I ..~_.__ ~~__._ _.10B. En.a BIock.•••__.._._._ _.__•••_.._. ._•••__._._•••_ __• •__.._.. 1"0
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R ItIGIC)trfAL N
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Chemistry Review Data Sheet1. NDA 21-918
2. REVIIW#: 3
3. REVIEW DATE: April 17, 2009
4. ItEVlEWD: MiItoaJ. Sloan; ""D.
s. PREVIOUS DOCUMENTS:.,.--0ri1iMlAnMncIM-(BZ)M.a"_t(BZ)AIn.""(BZ)Ame8cIIIIat (Bl.)~(BC)
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11. RELATED!SUPPOltTING DOCUMENTS:
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Withheld Track Number: Chemistry-_'_
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