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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091348
Company: AUROBINDO PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/08/2010 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
02/21/2025 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
06/24/2024 SUPPL-18 Labeling-Package Insert, Labeling

Label is not available on this site.
09/21/2022 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
06/24/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
12/06/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
03/26/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

SULFAMETHOXAZOLE AND TRIMETHOPRIM

SUSPENSION;ORAL; 200MG/5ML;40MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 091348 AUROBINDO PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 077785 CHARTWELL MOLECULAR
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 214330 NOVITIUM PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 077612 PRASCO
SULFATRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 018615 PHARM ASSOC
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