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FDA ANDA · ANDA062761

CEPHALEXIN

Sponsor: TEVA

APPLICATION
ANDA062761
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-24
LATEST ACTION
2000-09-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CEPHALEXINDiscontinued
CEPHALEXIN EQ 500MG BASE · CAPSULE · ORAL

Approval history

2000-09-11Manufacturing (CMC) · Supplement 27AP
2000-02-23Manufacturing (CMC) · Supplement 24AP
2000-02-23Manufacturing (CMC) · Supplement 25AP
2000-02-23Manufacturing (CMC) · Supplement 23AP
1998-03-17Manufacturing (CMC) · Supplement 22AP
1996-07-16Labeling · Supplement 21AP
1994-07-18Manufacturing (CMC) · Supplement 20AP
1994-06-23Manufacturing (CMC) · Supplement 18AP
1994-06-23Manufacturing (CMC) · Supplement 19AP
1994-06-23Manufacturing (CMC) · Supplement 17AP
1993-12-22Manufacturing (CMC) · Supplement 15AP
1993-12-07Labeling · Supplement 16AP
1993-08-13Labeling · Supplement 14AP
1993-05-26Manufacturing (CMC) · Supplement 12AP
1993-05-26Manufacturing (CMC) · Supplement 13AP
1992-07-30Labeling · Supplement 11AP
1992-03-24Manufacturing (CMC) · Supplement 9AP
1992-02-27Labeling · Supplement 10AP
1988-03-10Manufacturing (CMC) · Supplement 6AP
1988-02-25Manufacturing (CMC) · Supplement 8AP
1987-04-24OriginalAP
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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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