MedPath

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
© Copyright 2025. All Rights Reserved by MedPath
Tibsovo - FDA Approval | MedPath