Details for New Drug Application (NDA): 210712

NDA 210712 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 210712

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

Pharmacology for NDA: 210712

Suppliers and Packaging for NDA: 210712

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	210712	ANDA	Walgreens	0363-0960	0363-0960-08	4 BOTTLE, PLASTIC in 1 BOX (0363-0960-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	210712	ANDA	Walgreens	0363-0960	0363-0960-24	1 BOTTLE, PLASTIC in 1 BOX (0363-0960-24) / 24 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:	Sep 6, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Sep 6, 2019	TE:		RLD:	No

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