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FDA ANDA · ANDA080142

SULFISOXAZOLE

Sponsor: ANI PHARMS

APPLICATION
ANDA080142
TYPE
ANDA
ORIGINAL APPROVAL
1974-03-06
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SULFISOXAZOLEDiscontinued
SULFISOXAZOLE 500MG · TABLET · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 72AP
2002-03-12Manufacturing (CMC) · Supplement 71AP
2000-01-28Manufacturing (CMC) · Supplement 69AP
1999-11-23Manufacturing (CMC) · Supplement 68AP
1999-11-05Manufacturing (CMC) · Supplement 66AP
1999-11-05Manufacturing (CMC) · Supplement 64AP
1999-11-05Manufacturing (CMC) · Supplement 67AP
1999-11-05Manufacturing (CMC) · Supplement 65AP
1999-08-20Manufacturing (CMC) · Supplement 63AP
1998-12-09Manufacturing (CMC) · Supplement 62AP
1997-05-30Manufacturing (CMC) · Supplement 61AP
1996-04-17Labeling · Supplement 60AP
1993-01-05Manufacturing (CMC) · Supplement 59AP
1992-08-14Manufacturing (CMC) · Supplement 58AP
1974-03-06OriginalAP
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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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