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Generated: April 25, 2017

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Details for New Drug Application (NDA): 076777

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NDA 076777 describes NICOTINE POLACRILEX, which is a drug marketed by Actavis Labs Ny Inc, Perrigo R And D, Watson Labs, Ivax Sub Teva Pharms, and Perrigo, and is included in thirty-four NDAs. It is available from forty-three suppliers. Additional details are available on the NICOTINE POLACRILEX profile page.

The generic ingredient in NICOTINE POLACRILEX is nicotine polacrilex. There are twenty-nine drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for NDA: 076777

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076777

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
nicotine polacrilex
GUM, CHEWING;BUCCAL 076777 ANDA L. Perrigo Company 0113-0456 0113-0456-60 20 BLISTER PACK in 1 CARTON (0113-0456-60) > 1 GUM, CHEWING in 1 BLISTER PACK
nicotine polacrilex
GUM, CHEWING;BUCCAL 076777 ANDA Walgreen Company 0363-0456 0363-0456-06 160 BLISTER PACK in 1 CARTON (0363-0456-06) > 1 GUM, CHEWING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 2MG BASE
Approval Date:Sep 16, 2004TE:RLD:No

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