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FDA NDA · NDA018242

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Sponsor: TEVA

APPLICATION
NDA018242
TYPE
NDA
ORIGINAL APPROVAL
1981-05-19
LATEST ACTION
2000-07-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2000-07-07Manufacturing (CMC) · Supplement 50AP
1998-02-02Labeling · Supplement 49AP
1996-07-12Manufacturing (CMC) · Supplement 48AP
1996-07-12Manufacturing (CMC) · Supplement 47AP
1996-03-18Manufacturing (CMC) · Supplement 46AP
1996-03-18Manufacturing (CMC) · Supplement 45AP
1995-01-12Manufacturing (CMC) · Supplement 41AP
1994-11-30Manufacturing (CMC) · Supplement 40AP
1994-06-17Manufacturing (CMC) · Supplement 39AP
1994-04-04Labeling · Supplement 37AP
1994-02-04Manufacturing (CMC) · Supplement 35AP
1994-02-04Manufacturing (CMC) · Supplement 38AP
1993-04-13Labeling · Supplement 36AP
1992-08-07Manufacturing (CMC) · Supplement 34AP
1991-02-23Labeling · Supplement 33AP
1989-12-04Labeling · Supplement 32AP
1988-11-07Manufacturing (CMC) · Supplement 31AP
1988-10-06Manufacturing (CMC) · Supplement 30AP
1988-06-13Manufacturing (CMC) · Supplement 28AP
1986-05-27Manufacturing (CMC) · Supplement 27AP
1986-05-27Manufacturing (CMC) · Supplement 26AP
1985-10-17Manufacturing (CMC) · Supplement 25AP
1985-10-17Manufacturing (CMC) · Supplement 24AP
1985-07-29Manufacturing (CMC) · Supplement 18AP
1985-03-25Manufacturing (CMC) · Supplement 20AP
1984-12-18Manufacturing (CMC) · Supplement 17AP
1984-12-18Manufacturing (CMC) · Supplement 23AP
1984-12-18Manufacturing (CMC) · Supplement 21AP
1984-12-18Manufacturing (CMC) · Supplement 22AP
1981-05-19OriginalAP
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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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