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
c85b2c62-3c33-4cbc-8b79-d5e17851a1b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2021
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code47335-323
Application NumberNDA022534
Product Classification
M
Marketing Category
C73594
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 4, 2021
FDA Product Classification
INGREDIENTS (4)
POLYSORBATE 80Inactive
Quantity: 0.54 g in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.004 g in 1 mL
Code: XF417D3PSL
Classification: IACT
DOCETAXEL ANHYDROUSActive
Quantity: 20 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB
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 Code47335-895
Application NumberNDA022534
Product Classification
M
Marketing Category
C73594
G
Generic Name
Docetaxel
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 4, 2021
FDA Product Classification
INGREDIENTS (4)
DOCETAXEL ANHYDROUSActive
Quantity: 80 mg in 4 mL
Code: 699121PHCA
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 2.16 g in 4 mL
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.016 g in 4 mL
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Quantity: 1.58 g in 4 mL
Code: 3K9958V90M
Classification: IACT