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Last Updated: November 6, 2025

Details for New Drug Application (NDA): 076778

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NDA 076778 describes NICOTINE POLACRILEX, which is a drug marketed by Fertin Pharma, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Aurobindo Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pld Acquisitions, and Ppi-dac, and is included in fifty NDAs. It is available from fifty-six suppliers. Additional details are available on the NICOTINE POLACRILEX profile page.

The generic ingredient in NICOTINE POLACRILEX is nicotine polacrilex. There are thirty drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for 076778

Tradename:	NICOTINE POLACRILEX
Applicant:	L Perrigo Co
Ingredient:	nicotine polacrilex
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GUM, CHEWING;BUCCAL			Strength	EQ 4MG BASE
Approval Date:	Sep 16, 2004	TE:		RLD:	No

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