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
a6f89dc3-a594-4b5b-8728-272e20c1ecb5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 3
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 Code68083-176
Application NumberANDA207325
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2023
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 Code68083-314
Application NumberANDA207325
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2023
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 Code68083-177
Application NumberANDA207325
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2023
FDA Product Classification
INGREDIENTS (2)
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT