Application 214621
- Type
- NDA
- Sponsor
- MYOVANT SCIENCES GMBH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ORGOVYX | RELUGOLIX | TABLET;ORAL | 120MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72974-120 | Orgovyx | relugolix | Myovant Sciences, Inc. | NDA | Current |
| 72974-120 | Orgovyx | relugolix | Myovant Sciences, Inc. | NDA | Current |
| 72974-120 | Orgovyx | relugolix | Myovant Sciences, Inc. | NDA | Current |
| 72974-120 | Orgovyx | relugolix | Myovant Sciences, Inc. | NDA | Current |
| 72974-120 | Orgovyx | relugolix | Myovant Sciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83702 | SUPPL | 2025-10-09 |
| 83697 | SUPPL | 2025-10-09 |
| 79941 | SUPPL | 2024-10-21 |
| 79922 | SUPPL | 2024-10-21 |
| 73916 | SUPPL | 2023-03-31 |
| 73909 | SUPPL | 2023-03-31 |
| 65866 | ORIG | 2021-01-07 |
| 65712 | ORIG | 2020-12-23 |
| 65622 | ORIG | 2020-12-18 |