Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212231
Company: SOMERSET

Products on ANDA 212231

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	80MG/ML;16MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212231

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2022	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/22/2022	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212231

SULFAMETHOXAZOLE AND TRIMETHOPRIM

INJECTABLE;INJECTION; 80MG/ML;16MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	80MG/ML;16MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206607	MYLAN LABS LTD
SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	80MG/ML;16MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212231	SOMERSET
SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	80MG/ML;16MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	073303	TEVA PHARMS USA