Docetaxel
These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCEDTAXEL injection, for intravenous use Initial U.S. Approval: 1996
Approved
Approval ID
ff7fb2c2-97a7-4716-a269-925ca30cf0f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
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 Code0143-9205
Application NumberANDA204490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (4)
DOCETAXELActive
Quantity: 20 mg in 1 mL
Code: 15H5577CQD
Classification: ACTIM
POLYSORBATE 80Inactive
Quantity: 0.54 g in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Quantity: 0.395 g in 1 mL
Code: 3K9958V90M
Classification: IACT
Docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9204
Application NumberANDA204490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (4)
ALCOHOLInactive
Quantity: 0.395 g in 1 mL
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DOCETAXELActive
Quantity: 20 mg in 1 mL
Code: 15H5577CQD
Classification: ACTIM
POLYSORBATE 80Inactive
Quantity: 0.54 g in 1 mL
Code: 6OZP39ZG8H
Classification: IACT