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FDA ANDA · ANDA086926

TOLBUTAMIDE

Sponsor: DAVA PHARMS INC

APPLICATION
ANDA086926
TYPE
ANDA
ORIGINAL APPROVAL
1980-02-05
LATEST ACTION
1991-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TOLBUTAMIDEDiscontinued
TOLBUTAMIDE 500MG · TABLET · ORAL

Approval history

1991-07-02Labeling · Supplement 11AP
1991-04-26Labeling · Supplement 10AP
1987-09-04Manufacturing (CMC) · Supplement 9AP
1982-03-24Manufacturing (CMC) · Supplement 5AP
1982-03-24Manufacturing (CMC) · Supplement 3AP
1982-03-24Manufacturing (CMC) · Supplement 1AP
1982-03-24Manufacturing (CMC) · Supplement 4AP
1980-02-05OriginalAP
VIEW ON DRUGS@FDA ↗

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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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