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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 018679

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NDA 018679 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 018679

Tradename:	TRIMETHOPRIM
Applicant:	Dr Reddys Labs Sa
Ingredient:	trimethoprim
Patents:	0

Pharmacology for NDA: 018679

Mechanism of Action	Cytochrome P450 2C8 Inhibitors Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors

Medical Subject Heading (MeSH) Categories for 018679

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

Suppliers and Packaging for NDA: 018679

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIMETHOPRIM	trimethoprim	TABLET;ORAL	018679	NDA	Mayne Pharma	51862-486	51862-486-01	100 TABLET in 1 BOTTLE (51862-486-01)
TRIMETHOPRIM	trimethoprim	TABLET;ORAL	018679	NDA	Dr. Reddy's Labratories Inc.	75907-043	75907-043-01	100 TABLET in 1 BOTTLE (75907-043-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jul 30, 1982	TE:	AB	RLD:	Yes

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