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FDA ANDA · ANDA088882

ACETAZOLAMIDE

Sponsor: HERITAGE PHARMA

APPLICATION
ANDA088882
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-22
LATEST ACTION
2001-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAZOLAMIDEDiscontinued
ACETAZOLAMIDE 250MG · TABLET · ORAL

Approval history

2001-04-25Manufacturing (CMC) · Supplement 11AP
1991-06-03Labeling · Supplement 9AP
1991-05-31Manufacturing (CMC) · Supplement 7AP
1991-01-28Manufacturing (CMC) · Supplement 8AP
1989-05-15Manufacturing (CMC) · Supplement 4AP
1989-05-15Manufacturing (CMC) · Supplement 5AP
1988-06-15Manufacturing (CMC) · Supplement 3AP
1985-10-22OriginalAP
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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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