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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204794

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NDA 204794 describes NICOTINE POLACRILEX, which is a drug marketed by Actavis Labs Ny Inc, Ivax Sub Teva Pharms, L Perrigo Co, Perrigo R And D, and Watson Labs, and is included in thirty-four NDAs. It is available from thirty-seven 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. Forty-one suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 204794
Applicant:Actavis Labs Ny Inc
Ingredient:nicotine polacrilex
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204794
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 204794 ANDA AMERISOURCE BERGEN 46122-448 N 46122-448-58
NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 204794 ANDA Chain Drug Consortium, LLC 68016-292 N 68016-292-44

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 2MG BASE
Approval Date:May 10, 2016TE:RLD:No

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