Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
EUGIA Pharma Specialities Limited
AuroMedics Pharma LLC
872201704
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docetaxel
Product Details
NDC Product Code
55150-380Application Number
ANDA214575Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
February 16, 2021DocetaxelActive
Code: 699121PHCAClass: ACTIBQuantity: 10 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 260 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.23 mL in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 4 mg in 1 mL
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQClass: IACT
Docetaxel
Product Details
NDC Product Code
55150-378Application Number
ANDA214575Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
February 16, 2021ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.23 mL in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 260 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 4 mg in 1 mL
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQClass: IACT
DocetaxelActive
Code: 699121PHCAClass: ACTIBQuantity: 10 mg in 1 mL
Docetaxel
Product Details
NDC Product Code
55150-379Application Number
ANDA214575Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
February 16, 2021POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 260 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.23 mL in 1 mL
DocetaxelActive
Code: 699121PHCAClass: ACTIBQuantity: 10 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 4 mg in 1 mL
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQClass: IACT