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Last Updated: October 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206394


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NDA 206394 describes NICOTINE POLACRILEX, which is a drug marketed by Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, and Pld Acquisitions, and is included in forty-seven NDAs. It is available from forty-five 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-seven suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 206394
Tradename:NICOTINE POLACRILEX
Applicant:Perrigo R And D
Ingredient:nicotine polacrilex
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206394
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 206394 ANDA L. Perrigo Company 0113-0704 0113-0704-06 160 BLISTER PACK in 1 CARTON (0113-0704-06) > 1 GUM, CHEWING in 1 BLISTER PACK
NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 206394 ANDA Walgreen Company 0363-1012 0363-1012-78 100 BLISTER PACK in 1 CARTON (0363-1012-78) > 1 GUM, CHEWING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 2MG BASE
Approval Date:Dec 15, 2016TE:RLD:No

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