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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 078546

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NDA 078546 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 078546

Tradename:	NICOTINE POLACRILEX
Applicant:	Perrigo R And D
Ingredient:	nicotine polacrilex
Patents:	0

Pharmacology for NDA: 078546

Suppliers and Packaging for NDA: 078546

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078546	ANDA	L. Perrigo Company	0113-0854	0113-0854-78	100 BLISTER PACK in 1 CARTON (0113-0854-78) / 1 GUM, CHEWING in 1 BLISTER PACK
NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078546	ANDA	Rite Aid Corporation	11822-0854	11822-0854-1	100 BLISTER PACK in 1 CARTON (11822-0854-1) / 1 GUM, CHEWING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	GUM, CHEWING;BUCCAL			Strength	EQ 4MG BASE
Approval Date:	May 24, 2007	TE:		RLD:	No

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