APPLICATION
NDA020536
TYPE
NDA
ORIGINAL APPROVAL
1996-07-03
LATEST ACTION
2002-07-23
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
NICOTROLDiscontinued
NICOTINE 15MG/16HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2000-09-01Manufacturing (CMC) · Supplement 6 · standardAP
1999-11-26Manufacturing (CMC) · Supplement 8 · standardAP
1999-11-26Manufacturing (CMC) · Supplement 7 · standardAP
1998-11-18Manufacturing (CMC) · Supplement 3 · standardAP
1997-08-11Labeling · Supplement 2 · standardAP
1997-04-01Manufacturing (CMC) · Supplement 1 · standardAP
1996-07-03Type 8 - Partial Rx to OTC Switch · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.