Tibsovo
These highlights do not include all the information needed to use TIBSOVO safely and effectively. See full prescribing information for TIBSOVO. TIBSOVO (ivosidenib tablets), for oral use Initial U.S. Approval: 2018
Approved
Approval ID
5b6d8ae8-bac8-4e1b-b1b4-7f9665e62de5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 12, 2022
Manufacturers
FDA
Agios Pharmaceuticals, Inc.
DUNS: 011567735
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ivosidenib
PRODUCT DETAILS
NDC Product Code71334-100
Application NumberNDA211192
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 3, 2019
Generic Nameivosidenib
INGREDIENTS (1)
IVOSIDENIBActive
Quantity: 250 mg in 1 1
Code: Q2PCN8MAM6
Classification: ACTIB