Etoposide
ETOPOSIDE INJECTION, USP
Approved
Approval ID
e0cd61b9-2375-4e3d-a610-d87dad962468
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2019
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Etoposide
PRODUCT DETAILS
NDC Product Code0143-9376
Application NumberANDA074290
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 4, 2019
Generic NameEtoposide
INGREDIENTS (6)
ETOPOSIDEActive
Quantity: 20 mg in 1 mL
Code: 6PLQ3CP4P3
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 80 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 650 mg in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 30 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
ALCOHOLInactive
Quantity: 0.305 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT