Part1 1VIAL, GLASS 5.7mL
Part2 1VIAL, GLASS 5.7mL
Part 1of2
JEVTANA
cabazitaxel injection, solution, concentrate
Product Information
NDC Product Code (Source) 0024-5823
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
cabazitaxel(cabazitaxel) cabazitaxel 60mg in1.5mL
Inactive Ingredients
Ingredient Name Strength
Polysorbate 80 1.56g in1.5mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0024-5823-15 5.7mLIn1VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201023 06/23/2010
Part 2of2
DILUENT
alcohol and water injection
Product Information
NDC Product Code (Source) 0024-5822
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
Inactive Ingredients
Ingredient Name Strength
alcohol
water
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0024-5822-01 5.7mLIn1VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201023 06/23/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201023 06/23/2010
Labeler -sanofi-aventis U.S. LLC(824676584)
Establishment
Name Address ID/FEI Operations
Aventis Pharma Ltd. 737163787 MANUFACTURE
