Etoposide
ETOPOSIDE INJECTION USP
Approved
Approval ID
4f850eb2-3542-43a0-90e8-bb37fa05cf15
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2020
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
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 Code16729-114
Application NumberANDA074513
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 9, 2020
Generic NameEtoposide
INGREDIENTS (6)
ALCOHOLInactive
Quantity: 0.305 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 80 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 30 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 650 mg in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
ETOPOSIDEActive
Quantity: 20 mg in 1 mL
Code: 6PLQ3CP4P3
Classification: ACTIB