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FDA ANDA · ANDA065307

CEFADROXIL

Sponsor: CHARTWELL RX

APPLICATION
ANDA065307
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-16
LATEST ACTION
2008-11-17
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

CEFADROXILDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML · FOR SUSPENSION · ORAL
CEFADROXILDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2008-11-17Labeling · Supplement 3AP
2008-08-18Labeling · Supplement 2AP
2008-02-25Labeling · Supplement 1AP
2006-10-16OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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