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Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019983

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NDA 019983 describes PROSTEP, which is a drug marketed by Aveva and is included in one NDA. Additional details are available on the PROSTEP profile page.

The generic ingredient in PROSTEP is nicotine. There are twenty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the nicotine profile page.

Summary for NDA: 019983

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength11MG/24HR
Approval Date:Dec 23, 1998TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength22MG/24HR
Approval Date:Dec 23, 1998TE:RLD:No

Expired Orange Book Patents for NDA: 019983

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aveva
PROSTEP
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL019983-003Dec 23, 19984,946,853► Subscribe
Aveva
PROSTEP
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL019983-004Dec 23, 19984,946,853► Subscribe
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Serving 500+ biopharmaceutical companies globally:

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Mallinckrodt

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