APPLICATION
ANDA070006
TYPE
ANDA
ORIGINAL APPROVAL
1984-11-14
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 27AP
1998-05-13Labeling · Supplement 26AP
1997-10-22Labeling · Supplement 25AP
1994-12-23Manufacturing (CMC) · Supplement 24AP
1994-10-11Manufacturing (CMC) · Supplement 23AP
1994-04-12Labeling · Supplement 22AP
1992-04-03Manufacturing (CMC) · Supplement 19AP
1992-04-03Manufacturing (CMC) · Supplement 21AP
1991-07-24Labeling · Supplement 18AP
1990-02-22Labeling · Supplement 17AP
1989-06-09Manufacturing (CMC) · Supplement 15AP
1989-05-17Labeling · Supplement 16AP
1987-12-08Manufacturing (CMC) · Supplement 14AP
1987-11-06Manufacturing (CMC) · Supplement 13AP
1987-03-31Manufacturing (CMC) · Supplement 11AP
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 6AP
1985-08-30Manufacturing (CMC) · Supplement 4AP
1984-11-14OriginalAP
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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