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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 215357

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NDA 215357 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 215357

Tradename:	NICOTINE POLACRILEX
Applicant:	Aurobindo Pharma Ltd
Ingredient:	nicotine polacrilex
Patents:	0

Pharmacology for NDA: 215357

Suppliers and Packaging for NDA: 215357

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	215357	ANDA	Aurohealth LLC	58602-722	58602-722-81	4 CONTAINER in 1 CARTON (58602-722-81) / 27 LOZENGE in 1 CONTAINER
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	215357	ANDA	Aurohealth LLC	58602-722	58602-722-84	3 CONTAINER in 1 CARTON (58602-722-84) / 27 LOZENGE in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	May 13, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	May 13, 2022	TE:		RLD:	No

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