Basic Information
Zortress
0078-0415
Regulatory Information
0078-0415
NDA021560
C73594
August 10, 2018
USA
These highlights do not include all the information needed to use ZORTRESS safely and effectively. See full prescribing information for ZORTRESS. ZORTRESS (everolimus) tablets, for oral useInitial U.S. Approval: 2010
HUMAN PRESCRIPTION DRUG LABEL
26
Company Information
002147023
Active Ingredients
Inactive Ingredients
CROSPOVIDONE
Code: 2S7830E561
Class Code: IACT
BUTYLATED HYDROXYTOLUENE
Code: 1P9D0Z171K
Class Code: IACT
ANHYDROUS LACTOSE
Code: 3SY5LH9PMK
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
Active Moieties
EVEROLIMUS
Code: 9HW64Q8G6G