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
3c853336-2533-48ff-8b02-1bdbe196ed6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2017
Manufacturers
FDA
Sanja Pharmaceuticals Company
DUNS: 078741518
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 Code57277-001
Application NumberANDA205529
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 9, 2017
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 Code57277-002
Application NumberANDA205529
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 9, 2017
FDA Product Classification
INGREDIENTS (2)
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT