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Application 210797
- Type
- NDA
- Sponsor
- CLIVUNEL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SCENESSE | AFAMELANOTIDE | IMPLANT;SUBCUTANEOUS | 16MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73372-0116 | SCENESSE | afamelanotide | CLINUVEL INC. | NDA | Current |
| 73372-0116 | SCENESSE | afamelanotide | CLINUVEL INC. | NDA | Current |
| 73372-0116 | SCENESSE | afamelanotide | CLINUVEL INC. | NDA | Current |
| 73372-0116 | SCENESSE | afamelanotide | CLINUVEL INC. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79384 | SUPPL | 2024-08-13 |
| 79378 | SUPPL | 2024-08-13 |
| 63911 | ORIG | 2020-07-15 |
| 60510 | ORIG | 2019-10-10 |
| 60508 | ORIG | 2019-10-10 |