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FDA ANDA · ANDA070048

COTRIM D.S.

Sponsor: TEVA

APPLICATION
ANDA070048
TYPE
ANDA
ORIGINAL APPROVAL
1985-03-18
LATEST ACTION
2014-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

COTRIM D.S.Discontinued
SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG · TABLET · ORAL

Approval history

2014-08-26Labeling · Supplement 40 · standardAP
2001-08-30Manufacturing (CMC) · Supplement 39AP
1997-01-07Manufacturing (CMC) · Supplement 38AP
1996-08-16Manufacturing (CMC) · Supplement 37AP
1996-04-22Labeling · Supplement 36AP
1995-10-03Manufacturing (CMC) · Supplement 35AP
1995-10-03Manufacturing (CMC) · Supplement 33AP
1995-10-03Manufacturing (CMC) · Supplement 34AP
1995-03-02Manufacturing (CMC) · Supplement 32AP
1994-04-04Labeling · Supplement 31AP
1994-01-26Manufacturing (CMC) · Supplement 29AP
1994-01-26Manufacturing (CMC) · Supplement 28AP
1994-01-26Manufacturing (CMC) · Supplement 30AP
1993-08-31Manufacturing (CMC) · Supplement 27AP
1993-06-29Manufacturing (CMC) · Supplement 23AP
1993-06-29Manufacturing (CMC) · Supplement 26AP
1993-04-01Manufacturing (CMC) · Supplement 25AP
1993-04-01Manufacturing (CMC) · Supplement 24AP
1992-11-23Manufacturing (CMC) · Supplement 22AP
1991-11-01Manufacturing (CMC) · Supplement 21AP
1991-06-17Labeling · Supplement 19AP
1991-06-17Manufacturing (CMC) · Supplement 20AP
1989-09-06Manufacturing (CMC) · Supplement 17AP
1988-01-12Manufacturing (CMC) · Supplement 18AP
1987-10-23Manufacturing (CMC) · Supplement 15AP
1987-07-23Manufacturing (CMC) · Supplement 11AP
1987-02-09Manufacturing (CMC) · Supplement 8AP
1987-02-09Manufacturing (CMC) · Supplement 6AP
1987-02-09Manufacturing (CMC) · Supplement 7AP
1987-01-08Manufacturing (CMC) · Supplement 10AP
1986-07-23Manufacturing (CMC) · Supplement 5AP
1986-04-08Manufacturing (CMC) · Supplement 4AP
1985-07-30Manufacturing (CMC) · Supplement 1AP
1985-03-18OriginalAP
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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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