Last Updated: June 9, 2026

Details for New Drug Application (NDA): 071816

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NDA 071816 describes UROPLUS DS, which is a drug marketed by Shionogi and is included in one NDA. Additional details are available on the UROPLUS DS profile page.

The generic ingredient in UROPLUS DS is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

Summary for 071816

Tradename:	UROPLUS DS
Applicant:	Shionogi
Ingredient:	sulfamethoxazole; trimethoprim
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	800MG;160MG
Approval Date:	Sep 28, 1987	TE:		RLD:	No

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