Details for New Drug Application (NDA): 074650

NDA 074650 describes SULFAMETHOXAZOLE AND TRIMETHOPRIM, which is a drug marketed by Abraxis Pharm, Bedford, Hikma, Hospira, Mylan Labs Ltd, Somerset, Teva Pharms Usa, Watson Labs, Ani Pharms, Aurobindo Pharma, Chartwell Molecular, Lupin Ltd, Novitium Pharma, Prasco, Teva, 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-seven NDAs. It is available from forty-six 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 074650

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

Pharmacology for NDA: 074650

Mechanism of Action

Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors

Suppliers and Packaging for NDA: 074650

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	074650	ANDA	Redpharm Drug, Inc.	67296-1502	67296-1502-1	100 mL in 1 BOTTLE (67296-1502-1)
SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	074650	ANDA	Redpharm Drug, Inc.	67296-1502	67296-1502-2	200 mL in 1 BOTTLE (67296-1502-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	200MG/5ML;40MG/5ML
Approval Date:	Dec 29, 1997	TE:		RLD:	No

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