Nilandron
NILANDRON (nilutamide) Tablets
Approved
Approval ID
5ccf0e9a-8935-4c8c-b883-b4967281eb4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 8, 2022
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nilutamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59212-111
Application NumberNDA020169
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nilutamide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 8, 2022
FDA Product Classification
INGREDIENTS (7)
NilutamideActive
Quantity: 150 mg in 1 1
Code: 51G6I8B902
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT