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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 074374

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NDA 074374 describes PRIMSOL, which is a drug marketed by Pangea and is included in two NDAs. Additional details are available on the PRIMSOL profile page.

The generic ingredient in PRIMSOL is trimethoprim hydrochloride. There are thirty-four drug master file entries for this compound. Additional details are available on the trimethoprim hydrochloride profile page.

Summary for 074374

Tradename:	PRIMSOL
Applicant:	Pangea
Ingredient:	trimethoprim hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 25MG BASE/5ML
Approval Date:	Jun 23, 1995	TE:		RLD:	No

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