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
1263799c-13dc-488b-b158-b834736a4e66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2021
Manufacturers
FDA
AuroMedics Pharma LLC
DUNS: 968961354
Products 3
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 Code55150-380
Application NumberANDA214575
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2021
FDA Product Classification
INGREDIENTS (5)
DOCETAXEL ANHYDROUSActive
Quantity: 10 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 260 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ALCOHOLInactive
Quantity: 0.23 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 4 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
Docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-378
Application NumberANDA214575
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2021
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Quantity: 0.23 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 260 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 4 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
DOCETAXEL ANHYDROUSActive
Quantity: 10 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB
Docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-379
Application NumberANDA214575
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2021
FDA Product Classification
INGREDIENTS (5)
POLYSORBATE 80Inactive
Quantity: 260 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ALCOHOLInactive
Quantity: 0.23 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
DOCETAXEL ANHYDROUSActive
Quantity: 10 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Quantity: 4 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT