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FDA NDA · NDA018854
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
Sponsor: WATSON LABS
APPLICATION
NDA018854
TYPE
NDA
ORIGINAL APPROVAL
1983-05-09
LATEST ACTION
2001-12-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTHDiscontinued
SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG · TABLET · ORAL
Approval history
2001-12-12Labeling · Supplement 37AP
2001-06-27Manufacturing (CMC) · Supplement 35AP
2001-04-25Manufacturing (CMC) · Supplement 36AP
2000-07-31Manufacturing (CMC) · Supplement 34AP
1998-08-03Manufacturing (CMC) · Supplement 31AP
1998-08-03Manufacturing (CMC) · Supplement 32AP
1998-08-03Manufacturing (CMC) · Supplement 30AP
1997-10-21Labeling · Supplement 29AP
1994-06-17Labeling · Supplement 28AP
1994-02-09Labeling · Supplement 27AP
1993-02-25Manufacturing (CMC) · Supplement 26AP
1992-01-29Manufacturing (CMC) · Supplement 24AP
1991-01-28Manufacturing (CMC) · Supplement 25AP
1990-06-29Manufacturing (CMC) · Supplement 23AP
1988-11-01Manufacturing (CMC) · Supplement 21AP
1988-11-01Manufacturing (CMC) · Supplement 20AP
1988-10-26Bioequivalence · Supplement 22AP
1988-09-01Manufacturing (CMC) · Supplement 19AP
1988-03-17Manufacturing (CMC) · Supplement 18AP
1988-03-09Manufacturing (CMC) · Supplement 17AP
1988-03-09Manufacturing (CMC) · Supplement 16AP
1988-01-13Manufacturing (CMC) · Supplement 15AP
1988-01-13Manufacturing (CMC) · Supplement 13AP
1988-01-13Manufacturing (CMC) · Supplement 14AP
1985-10-17Manufacturing (CMC) · Supplement 8AP
1985-10-03Manufacturing (CMC) · Supplement 9AP
1984-10-31Manufacturing (CMC) · Supplement 6AP
1983-05-09OriginalAP
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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