APPLICATION
NDA050614
TYPE
NDA
ORIGINAL APPROVAL
1987-10-29
LATEST ACTION
2001-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
KEFTABDiscontinued
CEPHALEXIN HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
KEFTABDiscontinued
CEPHALEXIN HYDROCHLORIDE EQ 333MG BASE · TABLET · ORAL
KEFTABDiscontinued
CEPHALEXIN HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
Approval history
2001-06-18Manufacturing (CMC) · Supplement 21 · standardAP
2000-12-15Manufacturing (CMC) · Supplement 20 · standardAP
1999-07-29Labeling · Supplement 19 · standardAP
1999-07-29Labeling · Supplement 18 · standardAP
1999-07-29Labeling · Supplement 16 · standardAP
1998-02-19Manufacturing (CMC) · Supplement 17 · standardAP
1993-09-02Manufacturing (CMC) · Supplement 15 · standardAP
1993-06-28Labeling · Supplement 13 · standardAP
1991-10-25Manufacturing (CMC) · Supplement 11 · standardAP
1991-09-06Labeling · Supplement 10 · standardAP
1991-03-08Manufacturing (CMC) · Supplement 8 · standardAP
1990-11-28Manufacturing (CMC) · Supplement 9 · standardAP
1988-05-16Manufacturing (CMC) · Supplement 14 · standardAP
1987-10-29Type 3 - New Dosage Form · Original · standardAP
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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