FDA.reportPublic FDA data

Application 020066

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NICORETTENICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASEYesYes
003NICORETTE (MINT)NICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASEYesNo
004NICORETTENICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0135-0158Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0158Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0226Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0226Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0230Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0230Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0242Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0242Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0355Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0355Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0467Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0467Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0475Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0475Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0533Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0533Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
29485-5270Nicorette Fruit Chill nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5270Nicorette Fruit Chill nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5270Nicorette Fruit Chill nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5270Nicorette Fruit Chill nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5271Nicorette White Mint nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5271Nicorette White Mint nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5271Nicorette White Mint nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5271Nicorette White Mint nicotine polacrilexNicotineMechanical Servants LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77185SUPPL 2024-01-04
77180SUPPL 2024-01-04
67477SUPPL2021-05-13
67184SUPPL2021-04-27
60977SUPPL2019-11-20
60976SUPPL2019-11-20
56484SUPPL2018-11-23
56534SUPPL2018-11-21
54651SUPPL2018-06-21
54549SUPPL2018-06-14
50746SUPPL2017-12-18
50745SUPPL2017-12-18
49989SUPPL2017-10-10
34228SUPPL2015-11-02
1974SUPPL2015-10-02
34227SUPPL2014-11-07
1973SUPPL2014-11-03
34226SUPPL2014-08-05
12171SUPPL2014-08-05
21099SUPPL2014-06-12
1972SUPPL2014-06-12
12169SUPPL2014-01-16
12170SUPPL2013-11-07
1971SUPPL2013-10-31
21098SUPPL2012-07-18
12168SUPPL2012-03-28
20467SUPPL2012-03-27
21097SUPPL2012-02-17
21096SUPPL2012-02-03
21095SUPPL2011-09-29
21094SUPPL2011-05-19
1970SUPPL2009-05-08
1969SUPPL2008-06-16
21093SUPPL2007-07-05
34225SUPPL2007-06-27
20466SUPPL2007-04-11
21092SUPPL2006-05-05
34224SUPPL2005-12-13
1968SUPPL2005-12-13
21090SUPPL2004-06-24
21091SUPPL2004-06-23
1967SUPPL2004-04-29
1966SUPPL2002-08-09
20465SUPPL2000-09-25
12167SUPPL2000-09-25
1965SUPPL2000-09-25
34223SUPPL1998-12-23
20464SUPPL1998-12-23
21089SUPPL1998-12-13