FDA.reportPublic FDA data

Application 020658

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 0.25MG BASEYesYes
002REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 0.5MG BASEYesNo
003REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 1MG BASEYesNo
004REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 2MG BASEYesNo
005REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 5MG BASEYesNo
006REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 3MG BASEYesNo
007REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 4MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0007-4890REQUIPropiniroleGlaxoSmithKline LLCNDACurrent
0007-4891REQUIPropiniroleGlaxoSmithKline LLCNDACurrent
0007-4892REQUIPropiniroleGlaxoSmithKline LLCNDACurrent
0007-4893REQUIPropiniroleGlaxoSmithKline LLCNDACurrent
0007-4894REQUIPropiniroleGlaxoSmithKline LLCNDACurrent
0007-4895REQUIPropiniroleGlaxoSmithKline LLCNDACurrent
0007-4896REQUIPropiniroleGlaxoSmithKline LLCNDACurrent
63629-3760REQUIPropiniroleBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68095SUPPL2021-07-15
68072SUPPL2021-07-14
62513SUPPL2020-04-09
62452SUPPL2020-04-06
48332SUPPL2017-05-09
48315SUPPL2017-05-09
46965SUPPL2017-01-24
45293SUPPL2016-09-15
41527SUPPL2016-02-03
35091SUPPL2014-09-02
35090SUPPL2014-09-02
35089SUPPL2014-09-02
35088SUPPL2014-09-02
25455SUPPL2014-09-02
12936SUPPL2014-09-02
3016SUPPL2014-09-02
3015SUPPL2014-09-02
3014SUPPL2014-09-02
3013SUPPL2014-09-02
25456SUPPL2012-03-23
44064ORIG2011-12-20
35087SUPPL2009-01-06
35086SUPPL2009-01-06
25454SUPPL2009-01-06
25453SUPPL2009-01-06
12935SUPPL2009-01-06
3012SUPPL2009-01-06
41526ORIG2007-07-17
20806SUPPL2006-05-16
25452SUPPL2005-05-17
12934SUPPL2005-05-17
3011SUPPL2003-06-22