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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 021105

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NDA 021105 describes SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE, which is a drug marketed by Able and is included in one NDA. Additional details are available on the SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE profile page.

The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE 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 021105

Tradename:	SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE
Applicant:	Able
Ingredient:	phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG,N/A,N/A;N/A,800MG,160MG
Approval Date:	Jun 26, 2001	TE:		RLD:	No

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