Application 214846
- Type
- NDA
- Sponsor
- MYOVANT SCIENCES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYFEMBREE | RELUGOLIX;ESTRADIOL;NORETHINDRONE ACETATE | TABLET;ORAL | 40MG;1MG;0.5MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72974-415 | Myfembree | relugolix, estradiol hemihydrate, and norethindrone acetate | Myovant Sciences, Inc. | NDA | Current |
| 72974-415 | Myfembree | relugolix, estradiol hemihydrate, and norethindrone acetate | Myovant Sciences, Inc. | NDA | Current |
| 72974-415 | Myfembree | relugolix, estradiol hemihydrate, and norethindrone acetate | Myovant Sciences, Inc. | NDA | Current |
| 72974-415 | Myfembree | relugolix, estradiol hemihydrate, and norethindrone acetate | Myovant Sciences, Inc. | NDA | Current |
| 72974-415 | Myfembree | relugolix, estradiol hemihydrate, and norethindrone acetate | Myovant Sciences, Inc. | NDA | Current |
| 72974-415 | Myfembree | relugolix, estradiol hemihydrate, and norethindrone acetate | Myovant Sciences, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83227 | SUPPL | 2025-08-29 |
| 83215 | SUPPL | 2025-08-28 |
| 79140 | SUPPL | 2024-07-22 |
| 79114 | SUPPL | 2024-07-18 |
| 78340 | SUPPL | 2024-05-02 |
| 78328 | SUPPL | 2024-05-01 |
| 73331 | SUPPL | 2023-01-30 |
| 73330 | SUPPL | 2023-01-30 |
| 73317 | SUPPL | 2023-01-30 |
| 73316 | SUPPL | 2023-01-30 |
| 71748 | SUPPL | 2022-08-08 |
| 71740 | SUPPL | 2022-08-08 |
| 67897 | ORIG | 2021-06-24 |
| 67611 | ORIG | 2021-05-27 |
| 67603 | ORIG | 2021-05-26 |