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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 010533

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NDA 010533 describes PBZ-SR, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the PBZ-SR profile page.

The generic ingredient in PBZ-SR 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 010533

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

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

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