Nilutamide

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 145588013

Effective Date

September 18, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nilutamide(150 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

62559-173

Application Number

ANDA207631

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 18, 2020

Ingredients

Code: 51G6I8B902Class: ACTIBQuantity: 150 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

DOCUSATE SODIUMInactive

Code: F05Q2T2JA0Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

CALCIUM STEARATEInactive

Code: 776XM7047LClass: IACT