Skip to contentApplication 205598
- Type
- NDA
- Sponsor
- NOVO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MACRILEN | MACIMORELIN ACETATE | FOR SOLUTION;ORAL | EQ 60MG BASE/POUCH | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0169-1401 | Macrilen | Macimorelin acetate | Novo Nordisk | NDA | Current |
| 0169-1401 | Macrilen | Macimorelin acetate | Novo Nordisk | NDA | Current |
| 71090-002 | Macrilen | Macimorelin acetate | Strongbridge U.S. Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61087 | SUPPL | 2019-12-06 |
| 52232 | ORIG | 2018-01-31 |
| 50825 | ORIG | 2017-12-27 |
| 50824 | ORIG | 2017-12-21 |