FDA.reportPublic FDA data

Application 020169

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NILANDRONNILUTAMIDETABLET;ORAL50MGNoNo
002NILANDRONNILUTAMIDETABLET;ORAL150MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59212-111NilandronNilutamideConcordia Pharmaceuticals Inc.NDACurrent
59212-111NilandronNilutamideConcordia Pharmaceuticals Inc.NDACurrent
59212-111NilandronNilutamideConcordia Pharmaceuticals Inc.NDACurrent
59212-111NilandronNilutamideConcordia Pharmaceuticals Inc.NDACurrent
66993-212NilutamideNilutamidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-212NilutamideNilutamidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
82454-0111NilandronNilutamideCENEXI HSCNDACurrent
82454-0212NilutamideNilutamideCENEXI HSCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57640ORIG2019-02-15
48455SUPPL2017-05-19
48448SUPPL2017-05-18
2133SUPPL2004-07-28