APPLICATION
ANDA086445
TYPE
ANDA
ORIGINAL APPROVAL
1979-04-10
LATEST ACTION
2009-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOLBUTAMIDEDiscontinued
TOLBUTAMIDE 500MG · TABLET · ORAL
Approval history
2009-11-12Labeling · Supplement 63AP
2001-09-27Labeling · Supplement 59AP
1998-02-25Manufacturing (CMC) · Supplement 57AP
1998-02-05Manufacturing (CMC) · Supplement 58AP
1993-11-03Manufacturing (CMC) · Supplement 56AP
1991-01-23Labeling · Supplement 54AP
1990-01-31Manufacturing (CMC) · Supplement 53AP
1989-08-08Labeling · Supplement 52AP
1987-08-28Manufacturing (CMC) · Supplement 51AP
1984-09-18Manufacturing (CMC) · Supplement 45AP
1982-03-18Manufacturing (CMC) · Supplement 43AP
1979-04-10OriginalAP
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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