Last Updated: November 8, 2026

Details for New Drug Application (NDA): 083149

NDA 083149 describes PBZ, which is a drug marketed by Novartis and is included in three NDAs. Additional details are available on the PBZ profile page.

The generic ingredient in PBZ is tripelennamine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the tripelennamine hydrochloride profile page.

Summary for 083149

Tradename:	PBZ
Applicant:	Novartis
Ingredient:	tripelennamine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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