← FDA DRUG APPROVALS

FDA NDA · NDA018615

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Sponsor: PHARM ASSOC

APPLICATION
NDA018615
TYPE
NDA
ORIGINAL APPROVAL
1983-01-07
LATEST ACTION
2025-02-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued, Prescription

Products

SULFATRIMDiscontinued
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML · SUSPENSION · ORAL
SULFATRIM PEDIATRICPrescription
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML · SUSPENSION · ORAL

Approval history

2025-02-21Labeling · Supplement 86 · standard — Label ↗AP
2024-06-24Labeling · Supplement 83 · standard — Letter ↗AP
2021-10-15Labeling · Supplement 80 · standard — Label ↗AP
2016-09-07Manufacturing (CMC) · Supplement 76 · unknownAP
2003-09-25Labeling · Supplement 56AP
2001-02-07Manufacturing (CMC) · Supplement 53AP
2000-11-13Manufacturing (CMC) · Supplement 52AP
1997-10-21Labeling · Supplement 51AP
1997-06-20Manufacturing (CMC) · Supplement 48AP
1997-02-28Manufacturing (CMC) · Supplement 47AP
1997-01-07Manufacturing (CMC) · Supplement 43AP
1997-01-07Manufacturing (CMC) · Supplement 41AP
1997-01-07Labeling · Supplement 46AP
1997-01-07Manufacturing (CMC) · Supplement 44AP
1997-01-07Labeling · Supplement 50AP
1997-01-07Manufacturing (CMC) · Supplement 40AP
1995-11-08Manufacturing (CMC) · Supplement 39AP
1994-12-19Labeling · Supplement 38AP
1994-02-16Labeling · Supplement 37AP
1993-11-03Manufacturing (CMC) · Supplement 35AP
1993-11-03Manufacturing (CMC) · Supplement 33AP
1993-11-03Manufacturing (CMC) · Supplement 36AP
1993-11-03Manufacturing (CMC) · Supplement 34AP
1993-03-05Bioequivalence · Supplement 32AP
1993-01-22Manufacturing (CMC) · Supplement 29AP
1991-07-24Manufacturing (CMC) · Supplement 30AP
1991-02-26Manufacturing (CMC) · Supplement 21AP
1991-02-26Manufacturing (CMC) · Supplement 22AP
1990-09-28Manufacturing (CMC) · Supplement 31AP
1990-05-08Labeling · Supplement 28AP
1990-01-12Labeling · Supplement 26AP
1988-12-15Manufacturing (CMC) · Supplement 25AP
1988-12-15Manufacturing (CMC) · Supplement 24AP
1988-11-01Labeling · Supplement 20AP
1988-09-08Manufacturing (CMC) · Supplement 18AP
1988-07-14Manufacturing (CMC) · Supplement 19AP
1987-11-27Manufacturing (CMC) · Supplement 13AP
1987-04-22Manufacturing (CMC) · Supplement 11AP
1987-04-22Manufacturing (CMC) · Supplement 12AP
1986-02-13Manufacturing (CMC) · Supplement 8AP
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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