APPLICATION
ANDA086141
TYPE
ANDA
ORIGINAL APPROVAL
1979-08-03
LATEST ACTION
1985-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOLBUTAMIDEDiscontinued
TOLBUTAMIDE 500MG · TABLET · ORAL
Approval history
1985-12-23Manufacturing (CMC) · Supplement 7AP
1982-12-03Manufacturing (CMC) · Supplement 5AP
1979-08-03OriginalAP
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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