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FDA ANDA · ANDA061969

CEPHALEXIN

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA061969
TYPE
ANDA
ORIGINAL APPROVAL
1976-04-26
LATEST ACTION
2006-02-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CEPHALEXINDiscontinued
CEPHALEXIN EQ 500MG BASE · CAPSULE · ORAL
CEPHALEXINDiscontinued
CEPHALEXIN EQ 250MG BASE · CAPSULE · ORAL

Approval history

2006-02-01Labeling · Supplement 28AP
2001-12-20Manufacturing (CMC) · Supplement 25AP
2001-01-31Manufacturing (CMC) · Supplement 24AP
1999-08-20Manufacturing (CMC) · Supplement 23AP
1998-12-28Manufacturing (CMC) · Supplement 21AP
1998-12-28Manufacturing (CMC) · Supplement 22AP
1998-12-09Manufacturing (CMC) · Supplement 20AP
1998-09-02Manufacturing (CMC) · Supplement 19AP
1998-06-10Labeling · Supplement 18AP
1997-05-30Manufacturing (CMC) · Supplement 17AP
1993-12-14Labeling · Supplement 16AP
1993-03-23Labeling · Supplement 15AP
1992-12-04Manufacturing (CMC) · Supplement 14AP
1992-11-12Labeling · Supplement 13AP
1992-11-10Manufacturing (CMC) · Supplement 12AP
1989-01-09Manufacturing (CMC) · Supplement 11AP
1976-04-26OriginalAP
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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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