Tibsovo is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Agios Pharmaceuticals, Inc.. The primary component is Ivosidenib.
Product ID | 71334-100_05b9d296-44dd-4ee6-9702-84d3b2c263d6 |
NDC | 71334-100 |
Product Type | Human Prescription Drug |
Proprietary Name | Tibsovo |
Generic Name | Ivosidenib |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2018-07-20 |
Marketing Category | NDA / NDA |
Application Number | NDA211192 |
Labeler Name | Agios Pharmaceuticals, Inc. |
Substance Name | IVOSIDENIB |
Active Ingredient Strength | 250 mg/1 |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2018-07-20 |
Marketing End Date | 2024-11-30 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA211192 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2018-07-20 |
Ingredient | Strength |
---|---|
IVOSIDENIB | 250 mg/1 |
SPL SET ID: | 5b6d8ae8-bac8-4e1b-b1b4-7f9665e62de5 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
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 |