Etoposide
Etoposide Injection, USP
Approved
Approval ID
fe870629-104d-4d67-a7c6-f53bc588121e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 2, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ETOPOSIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-104
Application NumberANDA074983
Product Classification
M
Marketing Category
C73584
G
Generic Name
ETOPOSIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 2, 2022
FDA Product Classification
INGREDIENTS (6)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
ETOPOSIDEActive
Quantity: 20 mg in 1 mL
Code: 6PLQ3CP4P3
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT