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FDA ANDA · ANDA062827

CEPHALEXIN

Sponsor: BARR

APPLICATION
ANDA062827
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-17
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CEPHALEXINDiscontinued
CEPHALEXIN EQ 500MG BASE · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 15AP
1997-04-01Labeling · Supplement 14AP
1995-12-15Manufacturing (CMC) · Supplement 13AP
1995-01-31Manufacturing (CMC) · Supplement 5AP
1995-01-11Manufacturing (CMC) · Supplement 6AP
1994-12-23Manufacturing (CMC) · Supplement 12AP
1993-10-15Labeling · Supplement 11AP
1992-04-03Manufacturing (CMC) · Supplement 8AP
1992-04-03Manufacturing (CMC) · Supplement 10AP
1989-03-08Manufacturing (CMC) · Supplement 4AP
1987-08-17OriginalAP
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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