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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 071259

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NDA 071259 describes TRIMETHOPRIM, which is a drug marketed by Dr Reddys Labs Sa, Novel Labs Inc, Novitium Pharma, Sun Pharm Industries, Teva, Watson Labs, Bausch And Lomb, Epic Pharma Llc, Sandoz, and Somerset Theraps Llc, and is included in eleven NDAs. It is available from six suppliers. Additional details are available on the TRIMETHOPRIM profile page.

The generic ingredient in TRIMETHOPRIM is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.

Summary for 071259

Tradename:	TRIMETHOPRIM
Applicant:	Teva
Ingredient:	trimethoprim
Patents:	0

Medical Subject Heading (MeSH) Categories for 071259

Anti-Infective Agents, Urinary
Antimalarials
Cytochrome P-450 CYP2C8 Inhibitors
Folic Acid Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 18, 1987	TE:		RLD:	No

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