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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 091349

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NDA 091349 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-eight 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-nine suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for 091349

Tradename:	NICOTINE POLACRILEX
Applicant:	Perrigo R And D
Ingredient:	nicotine polacrilex
Patents:	0

Pharmacology for NDA: 091349

Suppliers and Packaging for NDA: 091349

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	091349	ANDA	Wal-Mart Stores Inc	49035-365	49035-365-20	200 BLISTER PACK in 1 CARTON (49035-365-20) / 1 GUM, CHEWING in 1 BLISTER PACK
NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	091349	ANDA	Wal-Mart Stores Inc	49035-365	49035-365-60	20 BLISTER PACK in 1 CARTON (49035-365-60) / 1 GUM, CHEWING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	GUM, CHEWING;BUCCAL			Strength	EQ 2MG BASE
Approval Date:	Jul 20, 2011	TE:		RLD:	No

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