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FDA ANDA · ANDA070030
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
Sponsor: HERITAGE PHARMA AVET
APPLICATION
ANDA070030
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-19
LATEST ACTION
2022-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTHDiscontinued
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL
Approval history
2022-03-08Labeling · Supplement 40 · standardAP
2022-03-08Labeling · Supplement 41 · standardAP
2015-01-15Labeling · Supplement 39 · standardAP
2012-12-05Labeling · Supplement 38 · standardAP
2010-09-28Labeling · Supplement 36AP
2007-11-01Labeling · Supplement 35AP
2005-06-21Labeling · Supplement 34AP
2001-11-09Labeling · Supplement 29AP
2000-08-25Labeling · Supplement 27AP
2000-03-20Manufacturing (CMC) · Supplement 24AP
2000-03-20Manufacturing (CMC) · Supplement 25AP
1999-03-18Manufacturing (CMC) · Supplement 16AP
1999-03-18Manufacturing (CMC) · Supplement 17AP
1998-04-21Labeling · Supplement 15AP
1997-07-24Manufacturing (CMC) · Supplement 12AP
1997-04-24Manufacturing (CMC) · Supplement 14AP
1997-01-14Manufacturing (CMC) · Supplement 13AP
1996-05-10Labeling · Supplement 10AP
1995-02-08Manufacturing (CMC) · Supplement 7AP
1994-05-20Labeling · Supplement 8AP
1992-01-31Labeling · Supplement 6AP
1991-04-22Labeling · Supplement 5AP
1991-02-23Labeling · Supplement 4AP
1990-06-21Labeling · Supplement 3AP
1989-03-08Labeling · Supplement 2AP
1985-09-19OriginalAP
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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