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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076202

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NDA 076202 describes ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, which is a drug marketed by Gavis Pharms and Watson Labs and is included in two NDAs. Additional details are available on the ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE profile page.

The generic ingredient in ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE is acetaminophen; pentazocine hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; pentazocine hydrochloride profile page.

Summary for 076202

Tradename:	ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
Applicant:	Gavis Pharms
Ingredient:	acetaminophen; pentazocine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	650MG;EQ 25MG BASE
Approval Date:	Aug 2, 2002	TE:		RLD:	No

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