Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071017
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription AB No No
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/25/1986 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2014 SUPPL-64 Labeling-Package Insert

Label is not available on this site.

01/17/2013 SUPPL-63 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

09/28/2010 SUPPL-61 Labeling-Package Insert

Label is not available on this site.

08/09/2007 SUPPL-56 Labeling

Label is not available on this site.

11/29/2005 SUPPL-50 Labeling

Label is not available on this site.

01/27/2005 SUPPL-43 Labeling

Label is not available on this site.

12/06/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/2002 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/2002 SUPPL-33 Labeling

Label is not available on this site.

06/06/2002 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/2002 SUPPL-31 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/19/2001 SUPPL-29 Labeling

Label is not available on this site.

05/17/2002 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/2000 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/2000 SUPPL-25 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/16/2000 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

06/01/2000 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1999 SUPPL-21 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/14/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/05/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/14/1997 SUPPL-15 Labeling

Label is not available on this site.

09/29/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/19/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/28/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/21/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/26/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/09/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/31/1989 SUPPL-3 Labeling

Label is not available on this site.

09/23/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/04/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

SULFAMETHOXAZOLE AND TRIMETHOPRIM

TABLET;ORAL; 800MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTRIM DS SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription Yes AB 017377 SUN PHARM INDUSTRIES
SEPTRA DS SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 017376 MONARCH PHARMS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 076899 AMNEAL PHARMS NY
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 090624 AUROBINDO PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 078060 CHARTWELL MOLECULES
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 090828 GLENMARK GENERICS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 071017 SUN PHARM INDUSTRIES
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 076817 VISTA PHARMS

TABLET;ORAL; 400MG;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription Yes AB 017377 SUN PHARM INDUSTRIES
SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 017376 MONARCH PHARMS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 076899 AMNEAL PHARMS NY
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 090624 AUROBINDO PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 078060 CHARTWELL MOLECULES
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 090828 GLENMARK GENERICS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 071017 SUN PHARM INDUSTRIES
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 076817 VISTA PHARMS

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