OXALIPLATIN
These highlights do not include all the information needed to use oxaliplatin safely and effectively. See full prescribing information for oxaliplatin. OXALIPLATIN INJECTION, for intravenous use Initial U.S. Approval: 2002
Approved
Approval ID
a98b4070-822f-4fba-a844-690ff5556f0b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Winthrop U.S, a business of sanofi-aventis U.S. LLC
DUNS: 824676584
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxaliplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-1727
Application NumberNDA021759
Product Classification
M
Marketing Category
C73605
G
Generic Name
oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB
oxaliplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-1725
Application NumberNDA021759
Product Classification
M
Marketing Category
C73605
G
Generic Name
oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB