TIBSOVO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Servier Pharmaceutical Llc. The primary component is Ivosidenib.
| Product ID | 72694-617_50a8eef8-9d1b-4bcb-8587-773f560a39d4 |
| NDC | 72694-617 |
| Product Type | Human Prescription Drug |
| Proprietary Name | TIBSOVO |
| Generic Name | Ivosidenib |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-10-19 |
| Marketing Category | NDA / |
| Application Number | NDA211192 |
| Labeler Name | Servier Pharmaceutical LLC |
| Substance Name | IVOSIDENIB |
| Active Ingredient Strength | 250 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2021-10-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 71334-100 | Tibsovo | ivosidenib |
| 72694-617 | TIBSOVO | ivosidenib |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TIBSOVO 87556035 5587521 Live/Registered |
Agios Pharmaceuticals, Inc. 2017-08-04 |
![]() TIBSOVO 87556017 5587520 Live/Registered |
Agios Pharmaceuticals, Inc. 2017-08-04 |
![]() TIBSOVO 87122179 5444093 Live/Registered |
Agios Pharmaceuticals, Inc. 2016-07-31 |