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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073303
Company: TEVA PHARMS USA

Products on ANDA 073303

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 073303

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1991	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
04/29/2013	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/073303s030lbl.pdf
02/27/2013	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
04/29/2013	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
07/23/2002	SUPPL-8	Labeling		Label is not available on this site.
08/26/1998	SUPPL-7	Labeling		Label is not available on this site.
12/27/1996	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/03/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/26/1993	SUPPL-4	Labeling		Label is not available on this site.
11/03/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/05/1993	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/07/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 073303

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2013	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/073303s030lbl.pdf

Therapeutic Equivalents for ANDA 073303

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

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