FDA.reportPublic FDA data

Application 022460

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JALYNDUTASTERIDE; TAMSULOSIN HYDROCHLORIDECAPSULE;ORAL0.5MG;0.4MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0809JALYNdutasteride and tamsulosin hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0809JALYNdutasteride and tamsulosin hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0809JALYNdutasteride and tamsulosin hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0809JALYNdutasteride and tamsulosin hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0809JALYNdutasteride and tamsulosin hydrochlorideGlaxoSmithKline LLCNDACurrent
66993-580Dutasteride and Tamsulosin Hydrochloridedutasteride and tamsulosin hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-580Dutasteride and Tamsulosin Hydrochloridedutasteride and tamsulosin hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-580Dutasteride and Tamsulosin Hydrochloridedutasteride and tamsulosin hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65813SUPPL2021-01-04
65774SUPPL2020-12-28
50290SUPPL2017-11-03
50289SUPPL2017-11-03
29749SUPPL2013-04-30
29748SUPPL2013-04-30
7416SUPPL2013-04-30
38732SUPPL2013-04-29
38731SUPPL2013-04-29
17603SUPPL2013-04-29
7415SUPPL2012-06-29
17602SUPPL2012-06-28
23710ORIG2011-12-20
7414SUPPL2011-06-13
17601SUPPL2011-06-10
44757ORIG2011-02-03
22026ORIG2011-02-03
7413ORIG2010-06-16
17600ORIG2010-06-15
29747ORIG2010-03-22