Application 214662
- Type
- NDA
- Sponsor
- MIRUM PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIVMARLI | MARALIXIBAT CHLORIDE | SOLUTION;ORAL | 9.5MG | No | No |
| 002 | LIVMARLI | MARALIXIBAT CHLORIDE | SOLUTION;ORAL | EQ 19MG BASE/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 79378-110 | Livmarli | maralixibat chloride | Mirum Pharmaceuticals Inc. | NDA | Current |
| 79378-110 | Livmarli | maralixibat chloride | Mirum Pharmaceuticals Inc. | NDA | Current |
| 79378-110 | Livmarli | maralixibat chloride | Mirum Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79234 | SUPPL | 2026-04-15 |
| 79233 | SUPPL | 2026-04-15 |
| 80198 | SUPPL | 2024-11-12 |
| 80189 | SUPPL | 2024-11-12 |
| 79210 | SUPPL | 2024-07-25 |
| 79209 | SUPPL | 2024-07-25 |
| 77834 | SUPPL | 2024-03-14 |
| 77833 | SUPPL | 2024-03-14 |
| 77830 | SUPPL | 2024-03-14 |
| 77829 | SUPPL | 2024-03-14 |
| 73758 | SUPPL | 2023-03-14 |
| 73742 | SUPPL | 2023-03-14 |
| 70704 | SUPPL | 2022-04-05 |
| 70684 | SUPPL | 2022-04-04 |
| 69524 | ORIG | 2021-12-10 |
| 69046 | ORIG | 2021-10-21 |
| 68811 | ORIG | 2021-09-30 |
| 68809 | ORIG | 2021-09-29 |