Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076899
Company: AMNEAL PHARMS NY

Products on ANDA 076899

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076899

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2005	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
09/16/2022	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
09/16/2022	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
12/21/2014	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/20/2013	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/22/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/17/2011	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/14/2007	SUPPL-5	Labeling		Label is not available on this site.
09/16/2007	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/20/2008	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 076899

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 PHARMS LTD
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

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 PHARMS LTD
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