Application 125390
- Type
- BLA
- Sponsor
- AEGERION
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYALEPT | METRELEPTIN | INJECTABLE;INJECTION | 11.3MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 76431-210 | Myalept | metreleptin | Aegerion Pharmaceuticals, Inc. | BLA | Current |
| 76431-210 | Myalept | metreleptin | Amryt Pharmaceuticals DAC | BLA | Current |
| 76431-210 | Myalept | metreleptin | Aegerion Pharmaceuticals, Inc. | BLA | Current |
| 76431-210 | Myalept | metreleptin | Aegerion Pharmaceuticals, Inc. | BLA | Current |
| 76431-210 | Myalept | metreleptin | Amryt Pharmaceuticals DAC | BLA | Current |
| 76431-210 | Myalept | metreleptin | Amryt Pharmaceuticals DAC | BLA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 83384 | SUPPL | 2025-09-18 |
| 73937 | SUPPL | 2023-04-03 |
| 70362 | SUPPL | 2022-03-02 |
| 70361 | SUPPL | 2022-03-02 |
| 70307 | SUPPL | 2022-03-01 |
| 67757 | SUPPL | 2021-06-10 |
| 63966 | SUPPL | 2020-07-20 |
| 63149 | SUPPL | 2020-05-19 |
| 63090 | SUPPL | 2020-05-19 |
| 61511 | SUPPL | 2020-01-03 |
| 61307 | SUPPL | 2019-12-17 |
| 57066 | SUPPL | 2018-12-30 |
| 50718 | SUPPL | 2017-12-18 |
| 47260 | SUPPL | 2017-02-17 |
| 18905 | SUPPL | 2015-10-06 |
| 31959 | SUPPL | 2015-09-23 |
| 31958 | SUPPL | 2015-09-01 |
| 18904 | SUPPL | 2015-08-28 |
| 18903 | SUPPL | 2014-07-02 |
| 31957 | SUPPL | 2014-07-01 |
| 24368 | ORIG | 2014-04-11 |
| 22807 | ORIG | 2014-04-11 |
| 24089 | ORIG | 2014-03-12 |
| 31956 | ORIG | 2014-02-26 |
| 39952 | ORIG | 2014-02-25 |