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FDA NDA · NDA018894

TOLAZAMIDE

Sponsor: COSETTE

APPLICATION
NDA018894
TYPE
NDA
ORIGINAL APPROVAL
1984-10-03
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TOLAZAMIDEDiscontinued
TOLAZAMIDE 500MG · TABLET · ORAL
TOLAZAMIDEDiscontinued
TOLAZAMIDE 100MG · TABLET · ORAL
TOLAZAMIDEDiscontinued
TOLAZAMIDE 250MG · TABLET · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 19AP
2002-03-12Manufacturing (CMC) · Supplement 18AP
2000-01-28Manufacturing (CMC) · Supplement 16AP
1998-08-18Manufacturing (CMC) · Supplement 15AP
1995-12-07Manufacturing (CMC) · Supplement 12AP
1995-12-07Manufacturing (CMC) · Supplement 11AP
1995-06-30Labeling · Supplement 10AP
1994-06-13Labeling · Supplement 9AP
1986-11-28Manufacturing (CMC) · Supplement 6AP
1986-06-09Manufacturing (CMC) · Supplement 5AP
1986-03-13Manufacturing (CMC) · Supplement 4AP
1984-10-03OriginalAP
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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