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
65d254c0-67ad-42c4-b972-ad463b755b2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
Servier Pharmaceutical LLC
DUNS: 116608503
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ivosidenib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72694-617
Application NumberNDA211192
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivosidenib
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (12)
ivosidenibActive
Quantity: 250 mg in 1 1
Code: Q2PCN8MAM6
Classification: ACTIB
Silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MPA.S)Inactive
Code: 6N003M473W
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT