APPLICATION
ANDA074612
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-20
LATEST ACTION
2015-04-13
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
NICOTINEOver-the-counter
NICOTINE 7MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NICOTINEOver-the-counter
NICOTINE 14MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NICOTINEOver-the-counter
NICOTINE 21MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2015-04-13Labeling · Supplement 25 · standardAP
2010-02-16Labeling · Supplement 16AP
2007-10-30Labeling · Supplement 7AP
2002-02-27Manufacturing (CMC) · Supplement 8AP
2000-02-15Manufacturing (CMC) · Supplement 5AP
2000-02-15Manufacturing (CMC) · Supplement 6AP
1999-05-24Manufacturing (CMC) · Supplement 3AP
1999-05-24Manufacturing (CMC) · Supplement 1AP
1999-05-24Manufacturing (CMC) · Supplement 4AP
1999-05-24Manufacturing (CMC) · Supplement 2AP
1997-10-20OriginalAP
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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