Nilutamide
Rx only
Approved
Approval ID
d5740b8f-fbb3-4023-9133-9e359a9ab980
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2020
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
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 Code62559-173
Application NumberANDA207631
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nilutamide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2020
FDA Product Classification
INGREDIENTS (7)
NILUTAMIDEActive
Quantity: 150 mg in 1 1
Code: 51G6I8B902
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT