Docetaxel anhydrous
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
9fb533da-a7ba-4c2b-8e4f-8e336ba55d12
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 10, 2023
Manufacturers
FDA
Meitheal Pharmaceuticals Inc
DUNS: 080548348
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docetaxel anhydrous
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-144
Application NumberANDA209634
Product Classification
M
Marketing Category
C73584
G
Generic Name
Docetaxel anhydrous
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 22, 2022
FDA Product Classification
INGREDIENTS (5)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DOCETAXEL ANHYDROUSActive
Quantity: 10 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB