Manufacturing Establishments6
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Janssen Pharmaceuticals, Inc.
Janssen Products, LP
080236951
Janssen Pharmaceutica NV
Janssen Products, LP
400345889
Janssen Cilag SpA
Janssen Products, LP
542797928
Johnson & Johnson Private Limited
Janssen Products, LP
677603030
Janssen Ortho LLC
Janssen Products, LP
805887986
Catalent Pharma Solutions, LLC
Janssen Products, LP
829672745
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ERLEADA
Product Details
NDC Product Code
59676-604Application Number
NDA210951Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 17, 2024SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MPA.S)Inactive
Code: 24P2YXD2PWClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10NClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)Inactive
Code: 23ZQ42JZZHClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ApalutamideActive
Code: 4T36H88UA7Class: ACTIBQuantity: 240 mg in 1 1
ERLEADA
Product Details
NDC Product Code
59676-600Application Number
NDA210951Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 17, 2024SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MPA.S)Inactive
Code: 24P2YXD2PWClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ApalutamideActive
Code: 4T36H88UA7Class: ACTIBQuantity: 60 mg in 1 1