Details for New Drug Application (NDA): 208875

NDA 208875 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 208875

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

Pharmacology for NDA: 208875

Suppliers and Packaging for NDA: 208875

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	208875	ANDA	Advagen Pharma Limited	72888-186	72888-186-53	1 BOTTLE in 1 CARTON (72888-186-53) / 27 LOZENGE in 1 BOTTLE
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	208875	ANDA	Advagen Pharma Limited	72888-186	72888-186-54	3 BOTTLE in 1 CARTON (72888-186-54) / 27 LOZENGE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Oct 31, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Oct 31, 2019	TE:		RLD:	No

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