APPLICATION
ANDA070216
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-10
LATEST ACTION
2001-06-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG · TABLET · ORAL
Approval history
2001-06-27Manufacturing (CMC) · Supplement 23AP
2001-05-29Manufacturing (CMC) · Supplement 24AP
2000-07-07Manufacturing (CMC) · Supplement 22AP
1998-11-17Manufacturing (CMC) · Supplement 21AP
1998-11-17Manufacturing (CMC) · Supplement 20AP
1998-07-21Labeling · Supplement 19AP
1997-10-22Labeling · Supplement 17AP
1995-12-07Manufacturing (CMC) · Supplement 16AP
1994-05-11Manufacturing (CMC) · Supplement 14AP
1994-04-04Labeling · Supplement 15AP
1991-02-23Labeling · Supplement 13AP
1990-03-16Labeling · Supplement 12AP
1989-06-09Manufacturing (CMC) · Supplement 11AP
1988-03-14Manufacturing (CMC) · Supplement 9AP
1988-02-01Manufacturing (CMC) · Supplement 10AP
1986-12-12Manufacturing (CMC) · Supplement 7AP
1986-07-17Manufacturing (CMC) · Supplement 6AP
1986-06-10Manufacturing (CMC) · Supplement 5AP
1986-06-10Manufacturing (CMC) · Supplement 3AP
1986-06-10Manufacturing (CMC) · Supplement 2AP
1986-05-09Manufacturing (CMC) · Supplement 4AP
1985-09-10OriginalAP
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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