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FDA ANDA · ANDA070007

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Sponsor: MUTUAL PHARM

APPLICATION
ANDA070007
TYPE
ANDA
ORIGINAL APPROVAL
1984-11-14
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1998-12-01Manufacturing (CMC) · Supplement 32AP
1998-05-13Labeling · Supplement 31AP
1997-10-22Labeling · Supplement 30AP
1994-12-23Manufacturing (CMC) · Supplement 29AP
1994-10-11Manufacturing (CMC) · Supplement 28AP
1994-04-12Labeling · Supplement 27AP
1992-04-03Manufacturing (CMC) · Supplement 26AP
1992-04-03Manufacturing (CMC) · Supplement 24AP
1991-07-16Manufacturing (CMC) · Supplement 21AP
1991-07-16Manufacturing (CMC) · Supplement 22AP
1991-02-07Manufacturing (CMC) · Supplement 14AP
1990-02-22Labeling · Supplement 23AP
1989-07-13Manufacturing (CMC) · Supplement 20AP
1989-05-17Labeling · Supplement 19AP
1989-01-10Labeling · Supplement 18AP
1988-10-31Manufacturing (CMC) · Supplement 17AP
1987-04-03Manufacturing (CMC) · Supplement 12AP
1986-05-20Manufacturing (CMC) · Supplement 6AP
1986-05-20Manufacturing (CMC) · Supplement 9AP
1985-12-26Manufacturing (CMC) · Supplement 8AP
1985-11-15Manufacturing (CMC) · Supplement 2AP
1985-10-17Manufacturing (CMC) · Supplement 3AP
1985-08-30Manufacturing (CMC) · Supplement 5AP
1985-08-30Manufacturing (CMC) · Supplement 4AP
1984-11-14OriginalAP
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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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