Last Updated: September 24, 2026

Details for New Drug Application (NDA): 074973

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NDA 074973 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 is one drug master file entry for this compound. Additional details are available on the trimethoprim hydrochloride profile page.

Summary for 074973

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 50MG BASE/5ML
Approval Date:	Jan 24, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 074973

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pangea	PRIMSOL	trimethoprim hydrochloride	SOLUTION;ORAL	074973-001	Jan 24, 2000	5,763,449	⤷ Start Trial
Pangea	PRIMSOL	trimethoprim hydrochloride	SOLUTION;ORAL	074973-001	Jan 24, 2000	5,962,461	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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