FDA.reportPublic FDA data

Application 022008

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 2MG BASEYesYes
002REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 4MG BASEYesNo
004REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 8MG BASEYesNo
005REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 12MG BASEYesNo
006REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 6MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0007-4882REQUIPropinirole hydrochlorideGlaxoSmithKline LLCNDACurrent
0007-4882REQUIPropinirole hydrochlorideGlaxoSmithKline LLCNDACurrent
0007-4883REQUIPropinirole hydrochlorideGlaxoSmithKline LLCNDACurrent
0007-4883REQUIPropinirole hydrochlorideGlaxoSmithKline LLCNDACurrent
0007-4885REQUIPropinirole hydrochlorideGlaxoSmithKline LLCNDACurrent
0007-4887REQUIPropinirole hydrochlorideGlaxoSmithKline LLCNDACurrent
0007-4887REQUIPropinirole hydrochlorideGlaxoSmithKline LLCNDACurrent
0007-4888REQUIPropinirole hydrochlorideGlaxoSmithKline LLCNDACurrent
0007-4888REQUIPropinirole hydrochlorideGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68104SUPPL2021-07-16
68103SUPPL2021-07-16
68077SUPPL2021-07-14
68076SUPPL2021-07-14
47699SUPPL2017-03-24
47663SUPPL2017-03-24
38074SUPPL2014-09-03
38073SUPPL2014-09-03
16757SUPPL2014-09-03
16756SUPPL2014-09-03
29063SUPPL2014-09-02
29062SUPPL2014-09-02
6673SUPPL2014-09-02
6672SUPPL2014-09-02
29061SUPPL2009-04-16
16755SUPPL2009-04-16
21903ORIG2008-12-29
16754SUPPL2008-11-07
6671SUPPL2008-11-03
16753ORIG2008-07-09
29060ORIG2008-07-08
29059ORIG2008-06-20