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
fad0f147-6595-4412-87a7-2afca0192a96
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
FOSUN PHARMA USA INC.
DUNS: 080920998
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxaliplatin
PRODUCT DETAILS
NDC Product Code72266-161
Application NumberANDA207325
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJanuary 8, 2024
Generic NameOxaliplatin
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB
Oxaliplatin
PRODUCT DETAILS
NDC Product Code72266-162
Application NumberANDA207325
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJanuary 8, 2024
Generic NameOxaliplatin
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXALIPLATINActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB