Nilandron

Nilandron

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

Company

DUNS: 815240092

Effective Date

July 8, 2022

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

59212-111

Application Number

NDA020169

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 8, 2022

Ingredients

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

DOCUSATE SODIUMInactive

Code: F05Q2T2JA0Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSEInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT