FDA.reportPublic FDA data

Application 020165

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
004NICODERM CQNICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL21MG/24HRYesYes
005NICODERM CQNICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL14MG/24HRYesNo
006NICODERM CQNICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL7MG/24HRYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0135-0194NICODERMnicotineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0194NICODERMnicotineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0194NICODERMnicotineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0195NICODERMnicotineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0195NICODERMnicotineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0195NICODERMnicotineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0196NICODERMnicotineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0196NICODERMnicotineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0196NICODERMnicotineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
11673-194NICOTINEnicotineTarget CorporationNDACurrent
11673-194NICOTINEnicotineTarget CorporationNDACurrent
11673-194NicotinenicotineTarget CorporationNDACurrent
11673-195NicotinenicotineTarget CorporationNDACurrent
11673-195NICOTINEnicotineTarget CorporationNDACurrent
11673-195NICOTINEnicotineTarget CorporationNDACurrent
11673-196NICOTINEnicotineTarget CorporationNDACurrent
11673-196NICOTINEnicotineTarget CorporationNDACurrent
11673-196NicotinenicotineTarget CorporationNDACurrent
49035-194NICOTINEnicotineWal-Mart Stores IncNDA AUTHORIZED GENERICCurrent
49035-194NicotinenicotineWal-Mart Stores IncNDA AUTHORIZED GENERICCurrent
49035-194NICOTINEnicotineWal-Mart Stores IncNDA AUTHORIZED GENERICCurrent
49035-195NICOTINEnicotineWal-Mart Stores IncNDA AUTHORIZED GENERICCurrent
49035-195NicotinenicotineWal-Mart Stores IncNDA AUTHORIZED GENERICCurrent
49035-195NICOTINEnicotineWal-Mart Stores IncNDA AUTHORIZED GENERICCurrent
49035-196NICOTINEnicotineWal-Mart Stores IncNDA AUTHORIZED GENERICCurrent
49035-196NicotinenicotineWal-Mart Stores IncNDA AUTHORIZED GENERICCurrent
49035-196NICOTINEnicotineWal-Mart Stores IncNDA AUTHORIZED GENERICCurrent
68196-194NicotinenicotineSam's West IncNDACurrent
68196-194NicotinenicotineSam's West IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80889SUPPL 2025-01-21
80888SUPPL 2025-01-21
70408SUPPL2022-03-07
70407SUPPL2022-03-07
21255SUPPL2016-05-06
12295SUPPL2016-05-06
12294SUPPL2015-11-25
2132SUPPL2015-10-13
34338SUPPL2015-08-10
21254SUPPL2015-08-10
12293SUPPL2015-02-17
2131SUPPL2015-02-05
12292SUPPL2014-05-06
21252SUPPL2014-05-01
34337SUPPL2013-11-19
21253SUPPL2013-11-06
21251SUPPL2012-09-24
20516SUPPL2007-11-19
21250SUPPL2007-04-20
12291SUPPL2007-04-19
2130SUPPL2006-09-20
34336SUPPL2006-09-18
2129SUPPL2002-08-13