APPLICATION
ANDA070028
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-29
LATEST ACTION
2025-02-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML · SUSPENSION · ORAL
Approval history
2025-02-21Labeling · Supplement 35 · standardAP
2024-06-24Labeling · Supplement 34 · standardAP
2022-09-22Labeling · Supplement 33 · standardAP
2022-09-22Labeling · Supplement 32 · standardAP
2002-05-31Manufacturing (CMC) · Supplement 31AP
2001-05-29Manufacturing (CMC) · Supplement 28AP
2000-08-30Labeling · Supplement 29AP
1999-12-02Manufacturing (CMC) · Supplement 25AP
1999-12-02Manufacturing (CMC) · Supplement 26AP
1999-02-12Manufacturing (CMC) · Supplement 22AP
1999-02-12Manufacturing (CMC) · Supplement 21AP
1998-08-04Labeling · Supplement 20AP
1998-01-30Labeling · Supplement 19AP
1997-05-09Manufacturing (CMC) · Supplement 18AP
1996-02-22Manufacturing (CMC) · Supplement 16AP
1994-07-07Manufacturing (CMC) · Supplement 14AP
1994-07-07Manufacturing (CMC) · Supplement 12AP
1994-07-07Manufacturing (CMC) · Supplement 10AP
1994-07-07Manufacturing (CMC) · Supplement 15AP
1994-07-07Manufacturing (CMC) · Supplement 13AP
1994-07-07Manufacturing (CMC) · Supplement 11AP
1994-07-07Labeling · Supplement 9AP
1990-12-20Manufacturing (CMC) · Supplement 8AP
1990-12-20Manufacturing (CMC) · Supplement 6AP
1990-12-20Manufacturing (CMC) · Supplement 7AP
1990-06-28Labeling · Supplement 5AP
1990-06-28Labeling · Supplement 4AP
1987-04-28Manufacturing (CMC) · Supplement 1AP
1985-10-29OriginalAP
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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