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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 209519

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NDA 209519 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 209519

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

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Jul 2, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Jul 2, 2018	TE:		RLD:	No

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