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FDA ANDA · ANDA086574

TOLBUTAMIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA086574
TYPE
ANDA
ORIGINAL APPROVAL
1980-06-04
LATEST ACTION
2001-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TOLBUTAMIDEDiscontinued
TOLBUTAMIDE 500MG · TABLET · ORAL

Approval history

2001-05-09Manufacturing (CMC) · Supplement 25AP
1999-12-14Manufacturing (CMC) · Supplement 24AP
1991-12-23Labeling · Supplement 22AP
1986-12-17Manufacturing (CMC) · Supplement 21AP
1986-12-17Manufacturing (CMC) · Supplement 20AP
1986-02-27Manufacturing (CMC) · Supplement 18AP
1985-01-03Manufacturing (CMC) · Supplement 16AP
1983-04-15Manufacturing (CMC) · Supplement 11AP
1982-04-22Manufacturing (CMC) · Supplement 6AP
1982-04-22Manufacturing (CMC) · Supplement 10AP
1982-04-22Manufacturing (CMC) · Supplement 9AP
1982-04-22Manufacturing (CMC) · Supplement 5AP
1980-06-04OriginalAP
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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