Details for New Drug Application (NDA): 090711

NDA 090711 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-one suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for 090711

Tradename:	NICOTINE POLACRILEX
Applicant:	Ppi-dac
Ingredient:	nicotine polacrilex
Patents:	0

Pharmacology for NDA: 090711

Suppliers and Packaging for NDA: 090711

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	090711	ANDA	L. Perrigo Company	0113-1125	0113-1125-10	4 CONTAINER in 1 CARTON (0113-1125-10) / 27 LOZENGE in 1 CONTAINER
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	090711	ANDA	L. Perrigo Company	0113-1190	0113-1190-10	4 CONTAINER in 1 CARTON (0113-1190-10) / 27 LOZENGE in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Jul 10, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Jul 10, 2009	TE:		RLD:	No

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