on Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022334 03/31/2009
AFINITOR
everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0594
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G) EVEROLIMUS 2.5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CROSPOVIDONE (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to slightly yellow) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code LCL;NVR
Contains
Packging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0594-51 28 in 1 CARTON
1 NDC:0078-0594-61 1 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022334 07/09/2010
AFINITOR
everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0620
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G) EVEROLIMUS 7.5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CROSPOVIDONE (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (white to slightly yellow) Score no score
Shape OVAL (elongated tablets with a bevelled edge) Size 15mm
Flavor Imprint Code 7P5;NVR
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0620-51 28 in 1 CARTON
1 NDC:0078-0620-61 1 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022334 07/29/2011
AFINITOR DISPERZ
everolimus tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0626
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G) EVEROLIMUS 2 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9 |
