Basic Information
Isturisa
55292-320
Regulatory Information
55292-320
NDA212801
C73594
November 3, 2023
USA
These highlights do not include all the information needed to use ISTURISA safely and effectively. See full prescribing information for ISTURISA. ISTURISA (osilodrostat) tablets, for oral use Initial U.S. Approval: 2020
HUMAN PRESCRIPTION DRUG LABEL
5
Company Information
181699406
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
MANNITOL
Code: 3OWL53L36A
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
POLYETHYLENE GLYCOL 4000
Code: 4R4HFI6D95
Class Code: IACT
Active Moieties
OSILODROSTAT
Code: 5YL4IQ1078