ABRAXANE
These highlights do not include all the information needed to use ABRAXANE safely and effectively. See full prescribing information for ABRAXANE. ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(albumin-bound), for intravenous use Initial U.S. Approval: 2005
Approved
Approval ID
24d10449-2936-4cd3-b7db-a7683db721e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Abraxis BioScience, LLC
DUNS: 832108497
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paclitaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68817-134
Application NumberNDA021660
Product Classification
M
Marketing Category
C73594
G
Generic Name
Paclitaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 4, 2020
FDA Product Classification
INGREDIENTS (2)
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
PACLITAXELActive
Quantity: 100 mg in 20 mL
Code: P88XT4IS4D
Classification: ACTIB