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FDA ANDA · ANDA071633

TOLAZAMIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA071633
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-09
LATEST ACTION
2001-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TOLAZAMIDEDiscontinued
TOLAZAMIDE 100MG · TABLET · ORAL

Approval history

2001-05-09Manufacturing (CMC) · Supplement 13AP
2001-01-02Manufacturing (CMC) · Supplement 12AP
1996-04-03Manufacturing (CMC) · Supplement 11AP
1995-10-24Manufacturing (CMC) · Supplement 9AP
1995-10-24Manufacturing (CMC) · Supplement 10AP
1992-07-24Labeling · Supplement 7AP
1990-04-05Manufacturing (CMC) · Supplement 6AP
1988-11-08Manufacturing (CMC) · Supplement 1AP
1987-12-09OriginalAP
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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