← FDA DRUG APPROVALS

FDA NDA · NDA018812

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Sponsor: TEVA

APPLICATION
NDA018812
TYPE
NDA
ORIGINAL APPROVAL
1983-01-28
LATEST ACTION
2000-07-07
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML · SUSPENSION · ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML · SUSPENSION · ORAL

Approval history

2000-07-07Manufacturing (CMC) · Supplement 57AP
1998-02-02Labeling · Supplement 56AP
1997-12-16Manufacturing (CMC) · Supplement 55AP
1997-10-17Manufacturing (CMC) · Supplement 54AP
1997-07-08Manufacturing (CMC) · Supplement 44AP
1997-05-13Manufacturing (CMC) · Supplement 53AP
1996-12-04Manufacturing (CMC) · Supplement 51AP
1996-12-04Manufacturing (CMC) · Supplement 52AP
1995-09-25Manufacturing (CMC) · Supplement 49AP
1994-12-14Manufacturing (CMC) · Supplement 48AP
1994-05-16Manufacturing (CMC) · Supplement 47AP
1994-04-04Labeling · Supplement 46AP
1993-05-17Manufacturing (CMC) · Supplement 45AP
1992-05-13Labeling · Supplement 43AP
1992-05-13Manufacturing (CMC) · Supplement 42AP
1991-02-23Labeling · Supplement 41AP
1990-05-03Labeling · Supplement 40AP
1988-11-14Manufacturing (CMC) · Supplement 39AP
1988-11-14Manufacturing (CMC) · Supplement 33AP
1987-10-26Manufacturing (CMC) · Supplement 34AP
1987-07-30Manufacturing (CMC) · Supplement 32AP
1987-04-22Manufacturing (CMC) · Supplement 30AP
1987-04-22Manufacturing (CMC) · Supplement 31AP
1986-08-13Manufacturing (CMC) · Supplement 27AP
1986-08-13Manufacturing (CMC) · Supplement 28AP
1986-05-19Manufacturing (CMC) · Supplement 25AP
1986-05-19Manufacturing (CMC) · Supplement 26AP
1986-02-07Manufacturing (CMC) · Supplement 24AP
1986-02-07Manufacturing (CMC) · Supplement 23AP
1985-11-08Manufacturing (CMC) · Supplement 15AP
1985-11-08Manufacturing (CMC) · Supplement 13AP
1985-11-01Manufacturing (CMC) · Supplement 20AP
1985-11-01Manufacturing (CMC) · Supplement 21AP
1985-07-24Manufacturing (CMC) · Supplement 14AP
1985-06-17Manufacturing (CMC) · Supplement 17AP
1983-01-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →