Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090624
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription AB No No
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG 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
02/16/2010 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
12/21/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/08/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/02/2013 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/26/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

SULFAMETHOXAZOLE AND TRIMETHOPRIM

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
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET;ORAL Prescription No AB 070030 HERITAGE PHARMA

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
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET;ORAL Prescription No AB 070037 HERITAGE PHARMA

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