Docetaxel anhydrous

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 080548348

Effective Date

July 10, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Docetaxel(10 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

71288-144

Application Number

ANDA209634

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

February 22, 2022

Ingredients

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

POLYETHYLENE GLYCOL 300Inactive

Code: 5655G9Y8AQClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

Code: 699121PHCAClass: ACTIBQuantity: 10 mg in 1 mL