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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 210711

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NDA 210711 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 210711

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

Pharmacology for NDA: 210711

Suppliers and Packaging for NDA: 210711

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	210711	ANDA	Walgreens	0363-0979	0363-0979-27	27 LOZENGE in 1 BOTTLE, PLASTIC (0363-0979-27)
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	210711	ANDA	Walgreens	0363-0979	0363-0979-81	3 BOTTLE, PLASTIC in 1 BOX (0363-0979-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Oct 31, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Oct 31, 2019	TE:		RLD:	No

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