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FDA ANDA · ANDA087318

TOLBUTAMIDE

Sponsor: WATSON LABS

APPLICATION
ANDA087318
TYPE
ANDA
ORIGINAL APPROVAL
1981-03-31
LATEST ACTION
1991-08-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TOLBUTAMIDEDiscontinued
TOLBUTAMIDE 500MG · TABLET · ORAL

Approval history

1991-08-08Labeling · Supplement 22AP
1991-08-07Manufacturing (CMC) · Supplement 18AP
1991-07-10Manufacturing (CMC) · Supplement 20AP
1991-07-10Manufacturing (CMC) · Supplement 21AP
1991-01-28Manufacturing (CMC) · Supplement 19AP
1988-05-06Manufacturing (CMC) · Supplement 16AP
1988-05-06Manufacturing (CMC) · Supplement 17AP
1985-05-02Manufacturing (CMC) · Supplement 14AP
1985-05-02Manufacturing (CMC) · Supplement 13AP
1984-08-08Manufacturing (CMC) · Supplement 11AP
1984-02-17Manufacturing (CMC) · Supplement 8AP
1984-02-17Manufacturing (CMC) · Supplement 10AP
1984-02-17Manufacturing (CMC) · Supplement 9AP
1982-09-16Manufacturing (CMC) · Supplement 7AP
1981-03-31OriginalAP
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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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