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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 080785

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NDA 080785 describes TRIPELENNAMINE HYDROCHLORIDE, which is a drug marketed by Anabolic, Barr, Heather, Impax Labs, Lannett, Nylos, Parke Davis, and Watson Labs, and is included in eleven NDAs. Additional details are available on the TRIPELENNAMINE HYDROCHLORIDE profile page.

The generic ingredient in TRIPELENNAMINE HYDROCHLORIDE is tripelennamine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the tripelennamine hydrochloride profile page.

Summary for 080785

Tradename:	TRIPELENNAMINE HYDROCHLORIDE
Applicant:	Impax Labs
Ingredient:	tripelennamine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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