Last Updated: September 24, 2026

Details for New Drug Application (NDA): 074612


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NDA 074612 describes NICOTINE, which is a drug marketed by Difgen Pharms, Fertin Pharma, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Aurobindo Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pld Acquisitions, and Ppi-dac, and is included in fifty NDAs. It is available from sixteen suppliers. Additional details are available on the NICOTINE profile page.

The generic ingredient in NICOTINE is nicotine polacrilex. There are two drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 074612
Tradename:NICOTINE
Applicant:Difgen Pharms
Ingredient:nicotine
Patents:0
Pharmacology for NDA: 074612
Medical Subject Heading (MeSH) Categories for 074612
Ganglionic Stimulants
Nicotinic Agonists
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 0363-1243 0363-1243-01 14 POUCH in 1 CARTON (0363-1243-01) / 1 h in 1 POUCH
NICOTINE nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 074612 ANDA Walgreens 0363-1244 0363-1244-01 14 POUCH in 1 CARTON (0363-1244-01) / 1 h in 1 POUCH

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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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