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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 070022

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NDA 070022 describes SULFAMETHOPRIM, which is a drug marketed by Novel Labs Inc and is included in two NDAs. Additional details are available on the SULFAMETHOPRIM profile page.

The generic ingredient in SULFAMETHOPRIM 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 070022

Tradename:	SULFAMETHOPRIM
Applicant:	Novel Labs Inc
Ingredient:	sulfamethoxazole; trimethoprim
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG;80MG
Approval Date:	Feb 15, 1985	TE:		RLD:	No

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