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FDA ANDA · ANDA070514

TOLAZAMIDE

Sponsor: WATSON LABS

APPLICATION
ANDA070514
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-09
LATEST ACTION
1997-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TOLAZAMIDEDiscontinued
TOLAZAMIDE 250MG · TABLET · ORAL

Approval history

1997-06-03Manufacturing (CMC) · Supplement 10AP
1991-08-07Manufacturing (CMC) · Supplement 6AP
1991-01-28Manufacturing (CMC) · Supplement 7AP
1991-01-16Labeling · Supplement 8AP
1990-06-29Manufacturing (CMC) · Supplement 5AP
1988-06-29Manufacturing (CMC) · Supplement 3AP
1988-06-29Manufacturing (CMC) · Supplement 4AP
1988-06-29Manufacturing (CMC) · Supplement 2AP
1986-01-09OriginalAP
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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