Application 213793
- Type
- NDA
- Sponsor
- RHYTHM PHARMACEUTICALS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMCIVREE | SETMELANOTIDE | SOLUTION;SUBCUTANEOUS | 10MG/ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72829-010 | Imcivree | setmelanotide | Rhythm Pharmaceuticals, Inc | NDA | Current |
| 72829-010 | Imcivree | setmelanotide | Rhythm Pharmaceuticals, Inc | NDA | Current |
| 72829-010 | Imcivree | setmelanotide | Rhythm Pharmaceuticals, Inc | NDA | Current |
| 72829-010 | Imcivree | setmelanotide | Rhythm Pharmaceuticals, Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85504 | SUPPL | 2026-03-24 |
| 85450 | SUPPL | 2026-03-23 |
| 83184 | SUPPL | 2025-08-25 |
| 83183 | SUPPL | 2025-08-25 |
| 80711 | SUPPL | 2025-01-15 |
| 80697 | SUPPL | 2024-12-23 |
| 76591 | SUPPL | 2023-11-16 |
| 76581 | SUPPL | 2023-11-16 |
| 71347 | SUPPL | 2022-06-17 |
| 71340 | SUPPL | 2022-06-16 |
| 65729 | ORIG | 2020-12-23 |
| 65422 | ORIG | 2020-11-30 |
| 65358 | ORIG | 2020-11-27 |