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FDA NDA · NDA018598

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Sponsor: FOSUN PHARMA

APPLICATION
NDA018598
TYPE
NDA
ORIGINAL APPROVAL
1982-05-19
LATEST ACTION
2025-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTHDiscontinued
SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG · TABLET · ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL

Approval history

2025-02-21Labeling · Supplement 56 · standard — Label ↗AP
2024-06-24Labeling · Supplement 55 · standard — Letter ↗AP
2021-10-15Labeling · Supplement 54 · standard — Label ↗AP
2019-09-05Labeling · Supplement 52 · standard — Letter ↗AP
2011-02-03Labeling · Supplement 51AP
2008-02-20Labeling · Supplement 50AP
2000-06-23Manufacturing (CMC) · Supplement 41AP
2000-02-02Manufacturing (CMC) · Supplement 40AP
1998-01-07Labeling · Supplement 36AP
1996-10-08Manufacturing (CMC) · Supplement 34AP
1996-10-08Manufacturing (CMC) · Supplement 33AP
1996-07-11Labeling · Supplement 35AP
1996-05-03Labeling · Supplement 32AP
1996-05-03Manufacturing (CMC) · Supplement 30AP
1995-05-10Manufacturing (CMC) · Supplement 28AP
1995-05-10Manufacturing (CMC) · Supplement 27AP
1994-10-20Manufacturing (CMC) · Supplement 16AP
1994-10-20Manufacturing (CMC) · Supplement 17AP
1994-03-09Labeling · Supplement 19AP
1992-07-28Labeling · Supplement 18AP
1989-03-27Manufacturing (CMC) · Supplement 12AP
1989-03-27Manufacturing (CMC) · Supplement 13AP
1989-03-08Labeling · Supplement 15AP
1988-11-07Labeling · Supplement 14AP
1988-01-13Manufacturing (CMC) · Supplement 11AP
1987-08-18Manufacturing (CMC) · Supplement 9AP
1986-01-07Manufacturing (CMC) · Supplement 8AP
1985-07-29Manufacturing (CMC) · Supplement 7AP
1982-05-19OriginalAP
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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