← FDA DRUG APPROVALS

FDA NDA · NDA019983

PROSTEP

Sponsor: AVEVA

APPLICATION
NDA019983
TYPE
NDA
ORIGINAL APPROVAL
1992-01-28
LATEST ACTION
2002-10-04
ROUTE
Transdermal, TRANSDERMAL
DOSAGE FORM
Film, Extended Release, FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PROSTEPDiscontinued
NICOTINE 11MG/24HR · Film, Extended Release · Transdermal
PROSTEPDiscontinued
NICOTINE 22MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
PROSTEPDiscontinued
NICOTINE 22MG/24HR · Film, Extended Release · Transdermal
PROSTEPDiscontinued
NICOTINE 11MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2002-10-04Labeling · Supplement 17 · standard — Letter ↗AP
2002-01-18Labeling · Supplement 16 · standard — Label ↗AP
2001-05-07Manufacturing (CMC) · Supplement 14 · standardAP
2000-04-04Manufacturing (CMC) · Supplement 13 · standardAP
1998-12-23Efficacy · Supplement 12 · standard — Review ↗AP
1998-12-23Manufacturing (CMC) · Supplement 11 · standard — Review ↗AP
1996-01-26Labeling · Supplement 8 · standardAP
1993-04-01Manufacturing (CMC) · Supplement 4 · standardAP
1993-02-02Manufacturing (CMC) · Supplement 5 · standardAP
1993-02-02Manufacturing (CMC) · Supplement 6 · standardAP
1992-05-13Manufacturing (CMC) · Supplement 1 · standardAP
1992-01-28Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →