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FDA ANDA · ANDA065015

CEFADROXIL

Sponsor: RANBAXY LABS LTD

APPLICATION
ANDA065015
TYPE
ANDA
ORIGINAL APPROVAL
1999-06-22
LATEST ACTION
2002-03-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CEFADROXILDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE · CAPSULE · ORAL

Approval history

2002-03-22Labeling · Supplement 4AP
2002-03-22Manufacturing (CMC) · Supplement 3AP
1999-12-21Manufacturing (CMC) · Supplement 2AP
1999-12-21Manufacturing (CMC) · Supplement 1AP
1999-06-22Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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