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FDA ANDA · ANDA064156

CEFACLOR

Sponsor: RANBAXY

APPLICATION
ANDA064156
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-28
LATEST ACTION
2001-01-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CEFACLORDiscontinued
CEFACLOR EQ 500MG BASE · CAPSULE · ORAL
CEFACLORDiscontinued
CEFACLOR EQ 250MG BASE · CAPSULE · ORAL

Approval history

2001-01-31Manufacturing (CMC) · Supplement 5AP
2000-06-29Manufacturing (CMC) · Supplement 3AP
2000-02-23Labeling · Supplement 4AP
1999-08-30Labeling · Supplement 2AP
1999-04-26Manufacturing (CMC) · Supplement 1AP
1997-08-28OriginalAP
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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