Docetaxel
These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL injection, for intravenous use Initial U.S. Approval: 1996
Approved
Approval ID
3a49c281-8cfd-4698-a9df-90ba800058ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 4, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-678
Application NumberANDA215744
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 4, 2023
FDA Product Classification
INGREDIENTS (5)
DOCETAXEL ANHYDROUSActive
Quantity: 10 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 9/4/2023
**WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY
REACTIONS, and FLUID RETENTION**