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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

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Docetaxel anhydrous - FDA Drug Approval Details