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FDA ANDA · ANDA071259

TRIMETHOPRIM

Sponsor: TEVA

APPLICATION
ANDA071259
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-18
LATEST ACTION
2012-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRIMETHOPRIMDiscontinued
TRIMETHOPRIM 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2012-03-27Labeling · Supplement 27 — Label ↗AP
2002-05-15Manufacturing (CMC) · Supplement 17AP
2002-05-15Manufacturing (CMC) · Supplement 15AP
2002-05-15Labeling · Supplement 18AP
2002-05-15Manufacturing (CMC) · Supplement 16AP
2002-05-15Manufacturing (CMC) · Supplement 14AP
2000-07-07Manufacturing (CMC) · Supplement 13AP
2000-05-16Manufacturing (CMC) · Supplement 12AP
1997-04-16Manufacturing (CMC) · Supplement 10AP
1997-03-06Labeling · Supplement 11AP
1996-09-05Manufacturing (CMC) · Supplement 9AP
1995-07-17Manufacturing (CMC) · Supplement 5AP
1994-10-17Manufacturing (CMC) · Supplement 4AP
1993-03-01Manufacturing (CMC) · Supplement 3AP
1988-02-10Manufacturing (CMC) · Supplement 2AP
1987-10-28Manufacturing (CMC) · Supplement 1AP
1987-06-18OriginalAP
VIEW ON DRUGS@FDA ↗

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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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