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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 018452

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NDA 018452 describes SEPTRA, which is a drug marketed by Monarch Pharms and is included in three NDAs. Additional details are available on the SEPTRA profile page.

The generic ingredient in SEPTRA 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 018452

Tradename:	SEPTRA
Applicant:	Monarch Pharms
Ingredient:	sulfamethoxazole; trimethoprim
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	80MG/ML;16MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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