Application 209531
- Type
- NDA
- Sponsor
- BIOGEN IDEC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SPINRAZA | NUSINERSEN SODIUM | SOLUTION;INTRATHECAL | 12MG/5ML (2.4MG/ML) | Yes | Yes |
| 002 | SPINRAZA | NUSINERSEN SODIUM | SOLUTION;INTRATHECAL | EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML) | Yes | Yes |
| 003 | SPINRAZA | NUSINERSEN SODIUM | SOLUTION;INTRATHECAL | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64406-058 | Spinraza | Nusinersen | Biogen | NDA | Current |
| 64406-058 | Spinraza | Nusinersen | Biogen | NDA | Current |
| 64406-058 | Spinraza | Nusinersen | Biogen | NDA | Current |
| 64406-058 | Spinraza | Nusinersen | Biogen | NDA | Current |
| 64406-058 | Spinraza | Nusinersen | Biogen | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85598 | SUPPL | 2026-03-31 |
| 85572 | SUPPL | 2026-03-30 |
| 78117 | SUPPL | 2024-04-12 |
| 78116 | SUPPL | 2024-04-12 |
| 78115 | SUPPL | 2024-04-12 |
| 78114 | SUPPL | 2024-04-12 |
| 73583 | SUPPL | 2023-02-21 |
| 73569 | SUPPL | 2023-02-21 |
| 63606 | SUPPL | 2020-06-17 |
| 63598 | SUPPL | 2020-06-17 |
| 59150 | SUPPL | 2019-06-21 |
| 59149 | SUPPL | 2019-06-21 |
| 59115 | SUPPL | 2019-06-18 |
| 59116 | SUPPL | 2019-06-17 |
| 55938 | SUPPL | 2018-10-15 |
| 55896 | SUPPL | 2018-10-11 |
| 54237 | SUPPL | 2018-05-17 |
| 54236 | SUPPL | 2018-05-17 |
| 54215 | SUPPL | 2018-05-16 |
| 54214 | SUPPL | 2018-05-16 |
| 50496 | SUPPL | 2017-11-27 |
| 50472 | SUPPL | 2017-11-22 |
| 46895 | ORIG | 2017-01-18 |
| 46518 | ORIG | 2016-12-23 |
| 46517 | ORIG | 2016-12-23 |