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
70121-1223Application Number
ANDA209640Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 21, 2023DocetaxelActive
Code: 699121PHCAClass: ACTIBQuantity: 160 mg in 8 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 3.16 g in 8 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 4.32 g in 8 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 3.2 mg in 8 mL
Docetaxel
Product Details
NDC Product Code
70121-1222Application Number
ANDA209640Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 21, 2023DocetaxelActive
Code: 699121PHCAClass: ACTIBQuantity: 80 mg in 4 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 1.58 g in 4 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 1.6 mg in 4 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 2.16 g in 4 mL
Docetaxel
Product Details
NDC Product Code
70121-1221Application Number
ANDA209640Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 21, 2023ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.395 g in 1 mL
DocetaxelActive
Code: 699121PHCAClass: ACTIBQuantity: 20 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 0.4 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.54 g in 1 mL