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Generated: October 21, 2018

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Details for New Drug Application (NDA): 078326

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NDA 078326 describes NICOTINE POLACRILEX, which is a drug marketed by Actavis Labs Ny Inc, Ivax Sub Teva Pharms, L Perrigo Co, Perrigo R And D, Watson Labs, Watson Labs Inc, and Watson Labs Teva, and is included in thirty-six NDAs. It is available from forty-four 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-six suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 078326
Tradename:NICOTINE POLACRILEX
Applicant:Perrigo R And D
Ingredient:nicotine polacrilex
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078326
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078326 ANDA L. Perrigo Company 0113-0422 0113-0422-25 110 BLISTER PACK in 1 CARTON (0113-0422-25) > 1 GUM, CHEWING in 1 BLISTER PACK
NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078326 ANDA L. Perrigo Company 0113-0749 0113-0749-29 220 BLISTER PACK in 1 CARTON (0113-0749-29) > 1 GUM, CHEWING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 4MG BASE
Approval Date:Oct 30, 2006TE:RLD:No

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