ULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
TALC (UNII: 7SEV7J4R1U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SHELLAC (UNII: 46N107B71O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-720-30 6 in 1 BOX, UNIT-DOSE 02/13/2015
1 NDC:62856-720-05 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
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:62856-718
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-718-30 6 in 1 BOX 05/13/2016
1 NDC:62856-718-05 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 5
Part 2 4
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, RED 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 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 05/13/2016
LENVIMA
lenvatin |
