Oxaliplatin
These highlights do not include all the information needed to use OXALIPLATIN INJECTION safely and effectively. See full prescribing information for OXALIPLATIN INJECTION. OXALIPLATIN injection, for intravenous use Initial U.S. Approval: 2002
Approved
Approval ID
b6083405-9b45-4d2c-e053-2995a90ad9ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
BluePoint Laboratories
DUNS: 985523874
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 Code68001-468
Application NumberANDA204368
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB