Application 211192
- Type
- NDA
- Sponsor
- AGIOS PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIBSOVO | IVOSIDENIB | TABLET;ORAL | 250MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71334-100 | Tibsovo | ivosidenib | Agios Pharmaceuticals, Inc. | NDA | Current |
| 71334-100 | Tibsovo | ivosidenib | Agios Pharmaceuticals, Inc. | NDA | Current |
| 71334-100 | Tibsovo | ivosidenib | Agios Pharmaceuticals, Inc. | NDA | Current |
| 71334-100 | Tibsovo | ivosidenib | Agios Pharmaceuticals, Inc. | NDA | Current |
| 71334-100 | Tibsovo | ivosidenib | Agios Pharmaceuticals, Inc. | NDA | Current |
| 71334-100 | Tibsovo | ivosidenib | Agios Pharmaceuticals, Inc. | NDA | Current |
| 71334-100 | Tibsovo | ivosidenib | Agios Pharmaceuticals, Inc. | NDA | Current |
| 72694-617 | TIBSOVO | ivosidenib | Servier Pharmaceutical LLC | NDA | Current |
| 72694-617 | TIBSOVO | ivosidenib | Servier Pharmaceutical LLC | NDA | Current |
| 72694-617 | Tibsovo | ivosidenib | Servier Pharmaceuticals LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75946 | SUPPL | 2023-10-25 |
| 75934 | SUPPL | 2023-10-25 |
| 75904 | SUPPL | 2023-10-24 |
| 71156 | SUPPL | 2022-05-26 |
| 71153 | SUPPL | 2022-05-26 |
| 71152 | SUPPL | 2022-05-26 |
| 68482 | SUPPL | 2021-08-30 |
| 68472 | SUPPL | 2021-08-26 |
| 68465 | SUPPL | 2021-08-25 |
| 66824 | SUPPL | 2021-03-22 |
| 62196 | SUPPL | 2020-03-19 |
| 58565 | SUPPL | 2019-05-06 |
| 58531 | SUPPL | 2019-05-02 |
| 55173 | ORIG | 2018-08-15 |
| 54928 | ORIG | 2018-07-20 |
| 54927 | ORIG | 2018-07-20 |
| 54926 | ORIG | 2018-07-20 |