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
67508df6-b96f-46fa-a792-0afcdfa9810e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 21, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
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 Code70121-1223
Application NumberANDA209640
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 21, 2023
FDA Product Classification
INGREDIENTS (4)
DOCETAXEL ANHYDROUSActive
Quantity: 160 mg in 8 mL
Code: 699121PHCA
Classification: ACTIB
ALCOHOLInactive
Quantity: 3.16 g in 8 mL
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 4.32 g in 8 mL
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 3.2 mg in 8 mL
Code: XF417D3PSL
Classification: IACT
Docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1222
Application NumberANDA209640
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 21, 2023
FDA Product Classification
INGREDIENTS (4)
DOCETAXEL ANHYDROUSActive
Quantity: 80 mg in 4 mL
Code: 699121PHCA
Classification: ACTIB
ALCOHOLInactive
Quantity: 1.58 g in 4 mL
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 1.6 mg in 4 mL
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 2.16 g in 4 mL
Code: 6OZP39ZG8H
Classification: IACT
Docetaxel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1221
Application NumberANDA209640
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 21, 2023
FDA Product Classification
INGREDIENTS (4)
ALCOHOLInactive
Quantity: 0.395 g in 1 mL
Code: 3K9958V90M
Classification: IACT
DOCETAXEL ANHYDROUSActive
Quantity: 20 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.4 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.54 g in 1 mL
Code: 6OZP39ZG8H
Classification: IACT