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FDA ANDA · ANDA071017

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA071017
TYPE
ANDA
ORIGINAL APPROVAL
1986-08-25
LATEST ACTION
2022-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG · TABLET · ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL

Approval history

2022-03-31Labeling · Supplement 72 · standardAP
2022-03-31Labeling · Supplement 70 · standardAP
2014-12-13Labeling · Supplement 64 · standardAP
2013-01-17Labeling · Supplement 63 · standardAP
2010-09-28Labeling · Supplement 61AP
2007-08-09Labeling · Supplement 56AP
2005-11-29Labeling · Supplement 50AP
2005-01-27Labeling · Supplement 43AP
2002-12-06Manufacturing (CMC) · Supplement 35AP
2002-10-11Labeling · Supplement 33AP
2002-08-09Manufacturing (CMC) · Supplement 34AP
2002-06-06Manufacturing (CMC) · Supplement 32AP
2002-06-03Manufacturing (CMC) · Supplement 31AP
2002-05-17Manufacturing (CMC) · Supplement 28AP
2001-11-19Labeling · Supplement 29AP
2001-03-14Manufacturing (CMC) · Supplement 27AP
2000-10-23Manufacturing (CMC) · Supplement 26AP
2000-10-23Manufacturing (CMC) · Supplement 25AP
2000-06-01Manufacturing (CMC) · Supplement 22AP
2000-05-16Manufacturing (CMC) · Supplement 24AP
2000-05-16Manufacturing (CMC) · Supplement 23AP
1999-10-14Manufacturing (CMC) · Supplement 21AP
1999-09-14Manufacturing (CMC) · Supplement 20AP
1999-08-05Manufacturing (CMC) · Supplement 17AP
1997-12-05Manufacturing (CMC) · Supplement 16AP
1997-10-14Labeling · Supplement 15AP
1997-09-29Manufacturing (CMC) · Supplement 14AP
1997-08-19Manufacturing (CMC) · Supplement 13AP
1997-02-28Manufacturing (CMC) · Supplement 11AP
1997-02-24Manufacturing (CMC) · Supplement 12AP
1996-08-21Manufacturing (CMC) · Supplement 10AP
1996-07-22Manufacturing (CMC) · Supplement 9AP
1995-06-22Manufacturing (CMC) · Supplement 8AP
1994-01-12Manufacturing (CMC) · Supplement 6AP
1992-10-26Manufacturing (CMC) · Supplement 5AP
1991-05-09Manufacturing (CMC) · Supplement 4AP
1989-10-31Labeling · Supplement 3AP
1988-09-23Manufacturing (CMC) · Supplement 2AP
1988-03-04Manufacturing (CMC) · Supplement 1AP
1986-08-25OriginalAP
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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