FDA.report

Application 020802

Type
NDA
Sponsor
GLAXOSMITHKLINE CONS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001EXCEDRIN (MIGRAINE)ACETAMINOPHEN; ASPIRIN; CAFFEINETABLET;ORAL250MG;250MG;65MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0067-2035ExcedrinAcetaminophen, Asprin, CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2035ExcedrinAcetaminophen, Asprin, CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2035ExcedrinAcetaminophen, Asprin, CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2039EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2039EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2039EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-8201EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
29485-8028EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeineAcetaminophen, Aspirin, and CaffeineMechanical Servants LLCNDACurrent
29485-8028EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeineAcetaminophen, Aspirin, and CaffeineMechanical Servants LLCNDACurrent
29485-8028EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeineAcetaminophen, Aspirin, and CaffeineMechanical Servants LLCNDACurrent
29485-8028EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeineAcetaminophen, Aspirin, and CaffeineMechanical Servants LLCNDACurrent
52904-871Excedrin Migraineacetaminophen, aspirin, and caffeineSelect CorporationNDACurrent
53808-0835EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineState of Florida DOH Central PharmacyNDACurrent
66715-9749Excedrin Migraineacetaminophen, aspirin, and caffeineLil' Drug Store Products, Inc.NDACurrent
66715-9749Excedrin Migraineacetaminophen, aspirin, and caffeineLil' Drug Store Products, Inc.NDACurrent
66715-9749Excedrin Migraineacetaminophen, aspirin, and caffeineLil' Drug Store Products, Inc.NDACurrent
69168-285Headache ReliefAcetaminophen, Aspirin and CaffeineAllegiant HealthNDACurrent
69168-285Headache ReliefAcetaminophen, Aspirin and CaffeineAllegiant HealthNDACurrent
69168-285Headache ReliefAcetaminophen, Aspirin and CaffeineAllegiant HealthNDACurrent

Documents

DocumentSubmission typeDate
74272SUPPL 2023-05-16
74267SUPPL 2023-05-16
74022SUPPL 2023-04-19
74021SUPPL 2023-04-19
69539SUPPL2021-12-13
69523SUPPL2021-12-09
69285SUPPL2021-11-09
69227SUPPL2021-11-04
61995SUPPL2020-02-28
61994SUPPL2020-02-28
50959SUPPL2019-04-19
58342SUPPL2019-04-16
58341SUPPL2019-04-16
50960SUPPL2018-01-09
50205SUPPL2017-10-27
50080SUPPL2017-10-18
13465SUPPL2014-07-30
3396SUPPL2014-07-17
13464SUPPL2014-04-22
25874SUPPL2014-04-17
25873SUPPL2010-02-17
25872SUPPL2007-02-12
41711ORIG2005-07-13
25871SUPPL2004-08-31
13463SUPPL2003-06-08
3395SUPPL2003-06-08
41712SUPPL1999-10-07
35388SUPPL1999-10-07
3394SUPPL1999-10-07