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FDA ANDA · ANDA070870

ACETOHEXAMIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA070870
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-09
LATEST ACTION
2002-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETOHEXAMIDEDiscontinued
ACETOHEXAMIDE 500MG · TABLET · ORAL
ACETOHEXAMIDEDiscontinued
ACETOHEXAMIDE 250MG · TABLET · ORAL

Approval history

2002-06-13Manufacturing (CMC) · Supplement 21AP
2001-10-26Labeling · Supplement 20AP
1999-12-21Manufacturing (CMC) · Supplement 19AP
1999-05-21Manufacturing (CMC) · Supplement 18AP
1999-05-20Manufacturing (CMC) · Supplement 17AP
1998-12-01Manufacturing (CMC) · Supplement 16AP
1995-05-03Manufacturing (CMC) · Supplement 15AP
1994-12-23Manufacturing (CMC) · Supplement 14AP
1994-11-29Manufacturing (CMC) · Supplement 13AP
1994-10-11Manufacturing (CMC) · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1991-10-28Labeling · Supplement 8AP
1991-09-11Labeling · Supplement 7AP
1991-08-02Manufacturing (CMC) · Supplement 4AP
1991-08-02Manufacturing (CMC) · Supplement 3AP
1990-12-13Bioequivalence · Supplement 6AP
1987-03-31Manufacturing (CMC) · Supplement 1AP
1987-02-09OriginalAP
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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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