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FDA NDA · NDA018679

TRIMETHOPRIM

Sponsor: DR REDDYS LABS SA

APPLICATION
NDA018679
TYPE
NDA
ORIGINAL APPROVAL
1982-07-30
LATEST ACTION
2016-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRIMETHOPRIM · ReferencePrescription
TRIMETHOPRIM 100MG · TABLET · ORAL

Approval history

2016-08-11Manufacturing (CMC) · Supplement 43 · standardAP
2016-06-13Labeling · Supplement 44 · standard — Label ↗AP
2012-07-12Labeling · Supplement 40 · standard — Label ↗AP
2008-02-11Labeling · Supplement 38AP
2003-06-18Labeling · Supplement 34AP
2002-05-15Manufacturing (CMC) · Supplement 28AP
2002-05-15Manufacturing (CMC) · Supplement 32AP
2002-05-15Manufacturing (CMC) · Supplement 30AP
2002-05-15Manufacturing (CMC) · Supplement 29AP
2002-05-15Manufacturing (CMC) · Supplement 33AP
2002-05-15Labeling · Supplement 31AP
2000-07-07Manufacturing (CMC) · Supplement 27AP
2000-05-16Manufacturing (CMC) · Supplement 26AP
1997-04-16Manufacturing (CMC) · Supplement 24AP
1997-03-06Labeling · Supplement 25AP
1996-09-05Manufacturing (CMC) · Supplement 23AP
1995-07-17Manufacturing (CMC) · Supplement 19AP
1995-02-16Manufacturing (CMC) · Supplement 20AP
1994-10-17Manufacturing (CMC) · Supplement 18AP
1993-03-01Manufacturing (CMC) · Supplement 16AP
1989-03-14Labeling · Supplement 17AP
1987-11-27Manufacturing (CMC) · Supplement 14AP
1987-11-27Manufacturing (CMC) · Supplement 15AP
1986-10-08Manufacturing (CMC) · Supplement 12AP
1986-05-19Manufacturing (CMC) · Supplement 10AP
1986-05-19Manufacturing (CMC) · Supplement 11AP
1986-04-07Manufacturing (CMC) · Supplement 5AP
1985-06-18Manufacturing (CMC) · Supplement 8AP
1985-02-06Manufacturing (CMC) · Supplement 6AP
1985-02-06Manufacturing (CMC) · Supplement 7AP
1982-07-30OriginalAP
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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