FDA.report

Application 021330

Type
NDA
Sponsor
GLAXOSMITHKLINE CONS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NICORETTENICOTINE POLACRILEXTROCHE/LOZENGE;ORALEQ 2MG BASEYesNo
002NICORETTENICOTINE POLACRILEXTROCHE/LOZENGE;ORALEQ 4MG BASEYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0135-0510NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0510NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0511NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0511NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0625NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0625NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0625NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0625NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0626NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0626NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0626NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0626NICORETTEnicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents

DocumentSubmission typeDate
79564SUPPL 2024-09-09
79563SUPPL 2024-09-09
69337SUPPL2021-11-17
69291SUPPL2021-11-10
62852SUPPL2020-05-08
58835SUPPL2019-05-22
58834SUPPL2019-05-22
52737SUPPL2018-02-27
52735SUPPL2018-02-27
52734SUPPL2018-02-27
52733SUPPL2018-02-27
48855SUPPL2017-06-28
36669SUPPL2015-10-22
5057SUPPL2015-10-02
15204SUPPL2015-08-10
5058SUPPL2015-08-10
27497SUPPL2015-05-20
15203SUPPL2015-05-20
36668SUPPL2014-08-25
5056SUPPL2014-08-15
15202SUPPL2013-11-07
5055SUPPL2013-10-29
27496SUPPL2013-08-08
27495SUPPL2012-05-29
27494SUPPL2010-08-31
5054SUPPL2010-01-15
5053SUPPL2008-05-28
5052SUPPL2006-09-18
15200SUPPL2006-09-15
36667SUPPL2005-11-30
5051SUPPL2005-11-30
27493SUPPL2005-11-01
15199SUPPL2005-11-01
21602ORIG2004-06-29
15198SUPPL2004-03-03
5050SUPPL2004-02-27
5049ORIG2002-10-31