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FDA ANDA · ANDA064081

CEFACLOR

Sponsor: TEVA

APPLICATION
ANDA064081
TYPE
ANDA
ORIGINAL APPROVAL
1996-09-16
LATEST ACTION
1999-05-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

1999-05-25Labeling · Supplement 5AP
1998-10-28Labeling · Supplement 4AP
1997-12-10Manufacturing (CMC) · Supplement 3AP
1997-01-10Manufacturing (CMC) · Supplement 1AP
1997-01-10Manufacturing (CMC) · Supplement 2AP
1996-09-16Original — Label ↗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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