Manufacturing Establishments9
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.
Janssen Biotech, Inc.
527224249
Changzhou SynTheAll Pharmaceutical Co., Ltd.
Janssen Biotech, Inc.
544385021
Zhejiang Xianju Junye Pharmaceutical Co., Ltd.
Janssen Biotech, Inc.
421340422
Pharmacia & Upjohn Company LLC
Janssen Biotech, Inc.
618054084
Johnson & Johnson Private Limited
Janssen Biotech, Inc.
677603030
Patheon France S.A.S
Janssen Biotech, Inc.
543127229
Janssen Cilag SpA
Janssen Biotech, Inc.
542797928
Shanghai SynTheAll Pharmaceutical Co., Ltd.
Janssen Biotech, Inc.
545342792
Janssen Pharmaceutica NV
Janssen Biotech, Inc.
400345889
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
AKEEGA
Product Details
NDC Product Code
57894-100Application Number
NDA216793Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
August 22, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10NClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
NiraparibActive
Code: 195Q483UZDClass: ACTIMQuantity: 100 mg in 1 1
AbirateroneActive
Code: EM5OCB9YJ6Class: ACTIBQuantity: 500 mg in 1 1
AKEEGA
Product Details
NDC Product Code
57894-050Application Number
NDA216793Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
August 22, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
NiraparibActive
Code: 195Q483UZDClass: ACTIMQuantity: 50 mg in 1 1
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10NClass: IACT
AbirateroneActive
Code: EM5OCB9YJ6Class: ACTIBQuantity: 500 mg in 1 1