APPLICATION
ANDA086109
TYPE
ANDA
ORIGINAL APPROVAL
1979-01-30
LATEST ACTION
1998-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOLBUTAMIDEDiscontinued
TOLBUTAMIDE 500MG · TABLET · ORAL
Approval history
1998-07-17Manufacturing (CMC) · Supplement 30AP
1997-05-23Manufacturing (CMC) · Supplement 29AP
1995-07-12Manufacturing (CMC) · Supplement 27AP
1994-08-17Manufacturing (CMC) · Supplement 28AP
1991-01-18Labeling · Supplement 26AP
1988-03-08Manufacturing (CMC) · Supplement 25AP
1987-12-17Manufacturing (CMC) · Supplement 24AP
1987-12-17Manufacturing (CMC) · Supplement 23AP
1986-05-15Manufacturing (CMC) · Supplement 21AP
1984-10-02Manufacturing (CMC) · Supplement 18AP
1983-01-27Manufacturing (CMC) · Supplement 14AP
1983-01-27Manufacturing (CMC) · Supplement 15AP
1979-01-30OriginalAP
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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