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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, Perrigo R And D, Watson Labs, Ivax Sub Teva Pharms, and Perrigo, and is included in thirty-two NDAs. It is available from forty 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-three suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for NDA: 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 0536-3386-01 10 BLISTER PACK in 1 CARTON (0536-3386-01) > 10 GUM, CHEWING in 1 BLISTER PACK
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL 079044 ANDA Rugby Laboratories 0536-3386 0536-3386-37 4 BLISTER PACK in 1 CARTON (0536-3386-37) > 10 GUM, CHEWING in 1 BLISTER PACK

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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