Oxaliplatin
These highlights do not include all the information needed to use OXALIPLATIN INJECTION, USP safely and effectively. See full prescribing information for OXALIPLATIN INJECTION, USP.OXALIPLATIN Injection, for intravenous use Initial U.S. Approval: 2002
Approved
Approval ID
e12e2850-4980-48de-af58-15e559fb921f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 7, 2021
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.
Oxaliplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-750
Application NumberANDA078811
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2020
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB