Last Updated: June 24, 2026

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 thirty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nicotine profile page.

Summary for 019983

Tradename:	PROSTEP
Applicant:	Aveva
Ingredient:	nicotine
Patents:	0

Medical Subject Heading (MeSH) Categories for 019983

Ganglionic Stimulants
Nicotinic Agonists

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	11MG/24HR
Approval Date:	Dec 23, 1998	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	22MG/24HR
Approval Date:	Dec 23, 1998	TE:		RLD:	No

Expired US Patents for NDA 019983

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aveva	PROSTEP	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	019983-003	Dec 23, 1998	4,946,853	⤷ Start Trial
Aveva	PROSTEP	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	019983-004	Dec 23, 1998	4,946,853	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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