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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 079216

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NDA 079216 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 079216

Tradename:	NICOTINE POLACRILEX
Applicant:	P And L
Ingredient:	nicotine polacrilex
Patents:	0

Pharmacology for NDA: 079216

Suppliers and Packaging for NDA: 079216

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	079216	ANDA	Walgreens	0363-9240	0363-9240-10	100 BLISTER PACK in 1 CARTON (0363-9240-10) / 1 GUM, CHEWING in 1 BLISTER PACK
NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	079216	ANDA	Walgreens	0363-9240	0363-9240-16	160 BLISTER PACK in 1 CARTON (0363-9240-16) / 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 8, 2009	TE:		RLD:	No

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