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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 016758

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NDA 016758 describes NAVANE, which is a drug marketed by Pfizer and is included in three NDAs. Additional details are available on the NAVANE profile page.

The generic ingredient in NAVANE is thiothixene hydrochloride. There are six drug master file entries for this compound. Additional details are available on the thiothixene hydrochloride profile page.

Summary for 016758

Tradename:	NAVANE
Applicant:	Pfizer
Ingredient:	thiothixene hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CONCENTRATE;ORAL			Strength	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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