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UBS
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Federal Trade Commission
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074612

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NDA 074612 describes NICOTINE, which is a drug marketed by Aveva, Actavis Labs Ny Inc, Ivax Sub Teva Pharms, L Perrigo Co, Perrigo R And D, and Watson Labs, and is included in thirty-five NDAs. It is available from thirteen suppliers. Additional details are available on the NICOTINE profile page.

The generic ingredient in NICOTINE 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 074612
Tradename:NICOTINE
Applicant:Aveva
Ingredient:nicotine
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 074612
Suppliers and Packaging for NDA: 074612
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICOTINE nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 074612 ANDA Walgreens 0363-1240 N 0363-1240-01
NICOTINE nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 074612 ANDA Walgreens 0363-1241 N 0363-1241-01

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength21MG/24HR
Approval Date:Oct 20, 1997TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength7MG/24HR
Approval Date:Jul 28, 2003TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength14MG/24HR
Approval Date:Oct 20, 1997TE:RLD:No

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