← FDA DRUG APPROVALS

FDA NDA · NDA020076

NICOTINE TRANSDERMAL SYSTEM

nicotine

Sponsor: DR REDDYS LABS SA

APPLICATION
NDA020076
TYPE
NDA
ORIGINAL APPROVAL
1991-11-27
LATEST ACTION
2019-01-02
ROUTE
TRANSDERMAL, Transdermal
DOSAGE FORM
FILM, EXTENDED RELEASE, Film, Extended Release
MARKETING STATUS
Over-the-counter, Discontinued

Products

HABITROL · ReferenceOver-the-counter
NICOTINE 7MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
HABITROLDiscontinued
NICOTINE 14MG/24HR · Film, Extended Release · Transdermal
HABITROL · ReferenceOver-the-counter
NICOTINE 14MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
HABITROLDiscontinued
NICOTINE 21MG/24HR · Film, Extended Release · Transdermal
HABITROLDiscontinued
NICOTINE 7MG/24HR · Film, Extended Release · Transdermal
HABITROL · ReferenceOver-the-counter
NICOTINE 21MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2019-01-02Labeling · Supplement 51 · standard — Letter ↗AP
2018-06-27Labeling · Supplement 49 · standard — Letter ↗AP
2017-07-23Labeling · Supplement 45 · standard — Letter ↗AP
2016-07-06Labeling · Supplement 42 · standard — Label ↗AP
2016-07-05Labeling · Supplement 43 · standard — Label ↗AP
2016-05-10Labeling · Supplement 41 · standard — Label ↗AP
2016-05-09Manufacturing (CMC) · Supplement 40 · standardAP
2016-04-04Manufacturing (CMC) · Supplement 39 · standardAP
2016-01-19Manufacturing (CMC) · Supplement 38 · standardAP
2015-11-17Manufacturing (CMC) · Supplement 37 · standardAP
2014-07-25Labeling · Supplement 36 · standard — Label ↗AP
2013-05-16Manufacturing (CMC) · Supplement 35 · standardAP
2006-05-05Labeling · Supplement 29 · standard — Letter ↗AP
2005-11-22Labeling · Supplement 28 · standard — Letter ↗AP
2004-10-21Manufacturing (CMC) · Supplement 27 · standard — Letter ↗AP
2004-02-06Labeling · Supplement 24 · standard — Letter ↗AP
2004-01-21Labeling · Supplement 25 · standard — Letter ↗AP
2002-07-15Labeling · Supplement 21 · standard — Label ↗AP
2002-07-12Labeling · Supplement 20 · standard — Letter ↗AP
2000-11-07Manufacturing (CMC) · Supplement 18 · standardAP
2000-01-31Manufacturing (CMC) · Supplement 17 · standardAP
1999-12-03Manufacturing (CMC) · Supplement 15 · standardAP
1999-11-12Efficacy · Supplement 11 · standard — Letter ↗AP
1999-01-07Efficacy · Supplement 13 · standardAP
1998-10-29Manufacturing (CMC) · Supplement 14 · standardAP
1996-07-24Manufacturing (CMC) · Supplement 9 · standardAP
1996-02-08Manufacturing (CMC) · Supplement 7 · standardAP
1995-10-06Manufacturing (CMC) · Supplement 10 · standardAP
1994-10-06Manufacturing (CMC) · Supplement 6 · standardAP
1992-07-21Manufacturing (CMC) · Supplement 3 · standardAP
1992-07-21Manufacturing (CMC) · Supplement 4 · standardAP
1992-01-06Manufacturing (CMC) · Supplement 1 · standardAP
1991-11-27Type 3 - New Dosage Form · Original · standardAP
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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.

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