Application 211855
- Type
- NDA
- Sponsor
- BIOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VUMERITY | DIROXIMEL FUMARATE | CAPSULE, DELAYED RELEASE;ORAL | 231MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64406-020 | Vumerity | diroximel fumarate | Biogen Inc. | NDA | Current |
| 64406-020 | Vumerity | diroximel fumarate | Biogen Inc. | NDA | Current |
| 64406-020 | Vumerity | diroximel fumarate | Biogen Inc. | NDA | Current |
| 64406-020 | Vumerity | diroximel fumarate | Biogen Inc. | NDA | Current |
| 64406-020 | Vumerity | diroximel fumarate | Biogen Inc. | NDA | Current |
| 64406-020 | Vumerity | diroximel fumarate | Biogen Inc. | NDA | Current |
| 64406-020 | Vumerity | diroximel fumarate | Biogen Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79617 | SUPPL | 2024-09-16 |
| 79584 | SUPPL | 2024-09-16 |
| 77942 | SUPPL | 2024-03-25 |
| 77933 | SUPPL | 2024-03-25 |
| 76832 | SUPPL | 2023-12-14 |
| 76804 | SUPPL | 2023-12-14 |
| 73494 | SUPPL | 2023-02-14 |
| 73469 | SUPPL | 2023-02-13 |
| 73253 | SUPPL | 2023-01-19 |
| 73189 | SUPPL | 2023-01-17 |
| 72220 | SUPPL | 2022-10-03 |
| 72217 | SUPPL | 2022-10-03 |
| 72190 | SUPPL | 2022-09-30 |
| 70150 | SUPPL | 2022-02-14 |
| 70148 | SUPPL | 2022-02-11 |
| 66051 | SUPPL | 2021-02-01 |
| 66037 | SUPPL | 2021-02-01 |
| 64483 | SUPPL | 2020-09-02 |
| 64403 | SUPPL | 2020-08-25 |
| 62622 | ORIG | 2020-04-21 |
| 60773 | ORIG | 2019-11-01 |
| 60731 | ORIG | 2019-10-30 |