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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 018598

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NDA 018598 describes SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, which is a drug marketed by Fosun Pharma, Heritage Pharma Avet, Martec Usa Llc, Mutual Pharm, Roxane, and Watson Labs, and is included in six NDAs. Additional details are available on the SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH profile page.

The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

Summary for 018598

Tradename:	SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
Applicant:	Fosun Pharma
Ingredient:	sulfamethoxazole; trimethoprim
Patents:	0

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG;80MG
Approval Date:	May 19, 1982	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	800MG;160MG
Approval Date:	May 19, 1982	TE:		RLD:	No

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