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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 214354

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NDA 214354 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 214354

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

Pharmacology for NDA: 214354

Suppliers and Packaging for NDA: 214354

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	214354	ANDA	Fertin Pharma A/S	63443-5057	63443-5057-1	10 BLISTER PACK in 1 CARTON (63443-5057-1) / 10 GUM, CHEWING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GUM, CHEWING;BUCCAL			Strength	EQ 4MG BASE
Approval Date:	Dec 21, 2022	TE:		RLD:	No

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