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
f59f7811-70b7-4c44-99f7-4f4fdce3ed22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2023
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docetaxel
PRODUCT DETAILS
NDC Product Code16729-231
Application NumberNDA201195
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateSeptember 21, 2023
Generic NameDocetaxel
INGREDIENTS (4)
ANHYDROUS CITRIC ACIDInactive
Quantity: 4 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 520 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ALCOHOLInactive
Quantity: 395 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
DOCETAXEL ANHYDROUSActive
Quantity: 20 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB
docetaxel
PRODUCT DETAILS
NDC Product Code16729-267
Application NumberNDA201195
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateSeptember 21, 2023
Generic Namedocetaxel
INGREDIENTS (4)
ANHYDROUS CITRIC ACIDInactive
Quantity: 4 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 520 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ALCOHOLInactive
Quantity: 395 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
DOCETAXEL ANHYDROUSActive
Quantity: 20 mg in 1 mL
Code: 699121PHCA
Classification: ACTIB