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 useInitial U.S. Approval: 2002
Approved
Approval ID
86f6c19d-30d1-42e3-8d46-5e3f45776e85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2023
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-9317
Application NumberANDA078817
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 25, 2016
FDA Product Classification
INGREDIENTS (2)
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Oxaliplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-9315
Application NumberANDA078817
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 25, 2016
FDA Product Classification
INGREDIENTS (2)
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT