nilutamide Oral Tablet

Brand(s)
Nilandron
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2009-11-17)
Oldest Current Product
1996-09-19
License(s)
NDA
RxNORM
ORAL TABLET\NILUTAMIDE
FDAOB
ORAL\TABLET\NILUTAMIDE
SPL Active
ORAL\TABLET\NILUTAMIDE
SPL Moiety
ORAL\TABLET\NILUTAMIDE

product(s) by strength(s)

nilutamide 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000881111NilandronNDASanofi-Aventis U.S. Llc1996-09-19NILUTAMIDEORALTABLETNDA0201696d2e5c32-3221-4605-955f-37c6bb61aef7

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020169NILANDRONCONCORDIA PHARMACEUTICALS INC1996-09-19NDA020169_001, NDA020169_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020169_001discontinuedNILUTAMIDE (50MG)ORALTABLETFalse1996-09-19NILANDRON
2NDA020169_002RXNILUTAMIDE (150MG)ORALTABLETTrue1999-04-30NILANDRON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16d2e5c32-3221-4605-955f-37c6bb61aef7 (view SPL)NILANDRON (nilutamide)TabletsprescriptionHuman PrescriptionSanofi-Aventis U.S. LlcMANUFACTURE2009-11-174000881111
2a682f5ef-c79f-419e-94b6-b1a84b7b6651 (view SPL)NILANDRON (nilutamide) TabletsprescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2014-06-273249870111

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII