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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 091348

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NDA 091348 describes SULFAMETHOXAZOLE AND TRIMETHOPRIM, which is a drug marketed by Abraxis Pharm, Bedford, Hikma, Hospira, Pharmobedient, Somerset, Teva Pharms Usa, Watson Labs, Ani Pharms, Aurobindo Pharma, Chartwell Molecular, Lupin Ltd, Novitium Pharma, Prasco, Teva, Aiping Pharm Inc, Amneal Pharms Ny, Chartwell Molecules, Fosun Pharma, Glenmark Pharms Ltd, Heather, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Sun Pharm Industries, Usl Pharma, Vista Pharms, Able, and Heritage Pharma Avet, and is included in forty-six NDAs. It is available from forty-four suppliers. Additional details are available on the SULFAMETHOXAZOLE AND TRIMETHOPRIM profile page.

The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM is phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim. There are eight drug master file entries for this compound. Additional details are available on the phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim profile page.

Summary for 091348

Tradename:	SULFAMETHOXAZOLE AND TRIMETHOPRIM
Applicant:	Aurobindo Pharma
Ingredient:	sulfamethoxazole; trimethoprim
Patents:	0

Pharmacology for NDA: 091348

Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors

Suppliers and Packaging for NDA: 091348

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	091348	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0496	17856-0496-4	72 CUP, UNIT-DOSE in 1 BOX (17856-0496-4) / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1)
SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	091348	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0496	17856-0496-5	50 CUP, UNIT-DOSE in 1 BOX (17856-0496-5) / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	200MG/5ML;40MG/5ML
Approval Date:	Jun 8, 2010	TE:	AB	RLD:	No

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