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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 213266

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NDA 213266 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 213266

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

Pharmacology for NDA: 213266

Suppliers and Packaging for NDA: 213266

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	213266	ANDA	Aurohealth LLC	58602-835	58602-835-07	1 CONTAINER in 1 CARTON (58602-835-07) / 24 LOZENGE in 1 CONTAINER
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	213266	ANDA	Aurohealth LLC	58602-835	58602-835-51	3 CONTAINER in 1 CARTON (58602-835-51) / 24 LOZENGE in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Aug 3, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Aug 3, 2021	TE:		RLD:	No

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