Manufacturing Establishments (3)
ISP Chemicals LLC
HRA Pharma Rare Diseases
078413681
Corden Pharma Latina S.p.A.
HRA Pharma Rare Diseases
339062883
Latina Pharma S.p.A.
HRA Pharma Rare Diseases
339062883
Products (1)
Lysodren
76336-080
NDA016885
NDA (C73594)
ORAL
January 19, 2024
mitotaneActive
Code: 78E4J5IB5JClass: ACTIBQuantity: 500 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5PClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MitotaneActive
Code: 78E4J5IB5JClass: ACTIBQuantity: 500 mg in 1 1
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT