ize 14mm
Flavor Imprint Code E;LENV;4;mg
Contains
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206947
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206947 02/13/2015
LENVIMA
lenvatinib kit
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-724
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-724-30 6 in 1 BOX 02/13/2015
1 NDC:62856-724-05 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 10
Part 2 5
Part 1 of 2
LENVATINIB
lenvatinib capsule
PRODUCT INFORMATION
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
LENVATINIB (UNII: EE083865G2) (LENVATINIB - UNII:EE083865G2) LENVATINIB 10 mg
PRODUCT CHARACTERISTICS
Color YELLOW (yellow body) , RED (yellowish-red cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code E;LENV;10;mg
Contains
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206947
Part 2 of 2
LENVATINIB
lenvatinib capsule
PRODUCT INFORMATION
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
LENVATINIB (UNII: EE083865G2) (LENVATINIB - UNII:EE083865G2) LENVATINIB 4 mg
PRODUCT CHARACTERISTICS
Color RED (yellowish-red cap and body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code E;LENV;4;mg
Contains
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206947
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206947 02/13/2015
LENVIMA
lenvatinib capsule
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-720
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
LENVATINIB (UNII: EE083865G2) (LENVATINIB - UNII:EE083865G2) LENVATINIB 10 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
HYDROXYPROPYL CELL |
