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Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 091348

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091348

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
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.

Therapeutic Equivalents for ANDA 091348

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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