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FDA ANDA · ANDA087093

TOLBUTAMIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA087093
TYPE
ANDA
ORIGINAL APPROVAL
1980-03-25
LATEST ACTION
2000-01-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TOLBUTAMIDEDiscontinued
TOLBUTAMIDE 500MG · TABLET · ORAL

Approval history

2000-01-28Manufacturing (CMC) · Supplement 40AP
1999-11-23Manufacturing (CMC) · Supplement 39AP
1999-08-20Manufacturing (CMC) · Supplement 38AP
1998-12-09Manufacturing (CMC) · Supplement 37AP
1998-10-26Manufacturing (CMC) · Supplement 35AP
1998-10-26Manufacturing (CMC) · Supplement 36AP
1997-05-30Manufacturing (CMC) · Supplement 34AP
1993-04-26Manufacturing (CMC) · Supplement 33AP
1992-10-05Manufacturing (CMC) · Supplement 32AP
1991-10-28Labeling · Supplement 31AP
1987-11-03Manufacturing (CMC) · Supplement 29AP
1987-11-03Manufacturing (CMC) · Supplement 28AP
1987-11-03Manufacturing (CMC) · Supplement 30AP
1987-04-07Manufacturing (CMC) · Supplement 27AP
1987-04-07Manufacturing (CMC) · Supplement 25AP
1987-04-07Manufacturing (CMC) · Supplement 26AP
1987-04-07Manufacturing (CMC) · Supplement 24AP
1982-04-21Manufacturing (CMC) · Supplement 19AP
1980-03-25OriginalAP
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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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