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
873fa936-157a-4f85-bc70-5df31d71d122
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2024
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
Products 1
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 Code71288-101
Application NumberANDA207325
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxaliplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2018
FDA Product Classification
INGREDIENTS (2)
waterInactive
Code: 059QF0KO0R
Classification: IACT
oxaliplatinActive
Quantity: 5 mg in 1 mL
Code: 04ZR38536J
Classification: ACTIB