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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079044

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NDA 079044 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-nine 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-three suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 079044
Tradename:NICOTINE POLACRILEX
Applicant:Watson Labs
Ingredient:nicotine polacrilex
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 079044
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 079044 ANDA Rugby Laboratories 0536-3386 N 0536-3386-01
NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 079044 ANDA Army and Air Force Exchange Service 55301-503 N 55301-503-44

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 2MG BASE
Approval Date:Jul 8, 2009TE:RLD:No

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