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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 087662

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NDA 087662 describes SULFAMETHOXAZOLE, which is a drug marketed by Ascot, Barr, Heather, Rising, Watson Labs, Abraxis Pharm, Bedford, Hikma, Hospira, Mylan Labs Ltd, Somerset, Teva Pharms Usa, Ani Pharms, Aurobindo Pharma, Chartwell Molecular, Lupin Ltd, Novitium Pharma, Prasco, Teva, Amneal Pharms Ny, Chartwell Molecules, Fosun Pharma, Glenmark Pharms Ltd, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Sun Pharm Industries, Usl Pharma, Vista Pharms, Able, and Heritage Pharma Avet, and is included in fifty-three NDAs. Additional details are available on the SULFAMETHOXAZOLE profile page.

The generic ingredient in SULFAMETHOXAZOLE 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 087662

Tradename:	SULFAMETHOXAZOLE
Applicant:	Ascot
Ingredient:	sulfamethoxazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 087662

Anti-Infective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Oct 20, 1982	TE:		RLD:	No

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