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
9e51cc79-620c-48d7-b267-78e43c1ef6e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2022
Manufacturers
FDA
Teva Parenteral Medicines, Inc.
DUNS: 794362533
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 Code0703-3985
Application NumberNDA022160
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (3)
OXALIPLATINActive
Quantity: 50 mg in 10 mL
Code: 04ZR38536J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Oxaliplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0703-3986
Application NumberNDA022160
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (3)
OXALIPLATINActive
Quantity: 100 mg in 20 mL
Code: 04ZR38536J
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT