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Generated: December 14, 2017

DrugPatentWatch Database Preview

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, and Watson Labs, and is included in thirty-four NDAs. It is available from forty-two 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-five suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for 078326

Tradename:1
Applicant:1
Ingredient:1
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 Major Pharmaceuticals 0904-5737 0904-5737-51 50 BLISTER PACK in 1 CARTON (0904-5737-51) > 1 GUM, CHEWING in 1 BLISTER PACK

Summary 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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