Details for New Drug Application (NDA): 212057

NDA 212057 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 forty-nine NDAs. It is available from sixty 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. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for 212057

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

Pharmacology for NDA: 212057

Suppliers and Packaging for NDA: 212057

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212057	ANDA	CVS Pharmacy	69842-964	69842-964-08	4 BOTTLE, PLASTIC in 1 BOX (69842-964-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212057	ANDA	CVS Pharmacy	69842-976	69842-976-08	4 BOTTLE, PLASTIC in 1 BOX (69842-976-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	May 14, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	May 14, 2020	TE:		RLD:	No

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