ETOPOPHOS
These highlights do not include all the information needed to use ETOPOPHOS safely and effectively. See full prescribing information for ETOPOPHOS. ETOPOPHOS(etoposide phosphate) for injection, for intravenous useInitial U.S. Approval: 1983
Approved
Approval ID
7499fc35-fae8-44ad-bbab-9a1a589bf3ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
H2-Pharma, LLC
DUNS: 028473634
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
etoposide phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-410
Application NumberNDA020457
Product Classification
M
Marketing Category
C73594
G
Generic Name
etoposide phosphate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 16, 2019
FDA Product Classification
INGREDIENTS (3)
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 32.7 mg in 1 1
Code: 1Q73Q2JULR
Classification: IACT
DEXTRAN 40Inactive
Quantity: 300 mg in 1 1
Code: K3R6ZDH4DU
Classification: IACT
etoposide phosphateActive
Quantity: 100 mg in 1 1
Code: 528XYJ8L1N
Classification: ACTIM