Application 214133
- Type
- NDA
- Sponsor
- STRONGBRIDGE DUBLIN LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RECORLEV | LEVOKETOCONAZOLE | TABLET; ORAL | 150MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72065-003 | Recorlev | Levoketoconazole | Xeris Pharmaceuticals, Inc. | NDA | Current |
| 72065-003 | Recorlev | Levoketoconazole | Xeris Pharmaceuticals, Inc. | NDA | Current |
| 72065-003 | Recorlev | Levoketoconazole | Xeris Pharmaceuticals, Inc. | NDA | Current |
| 72065-003 | Recorlev | Levoketoconazole | Xeris Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75134 | SUPPL | 2023-08-18 |
| 75131 | SUPPL | 2023-08-18 |
| 75099 | SUPPL | 2023-08-17 |
| 72248 | ORIG | 2022-10-05 |
| 71567 | ORIG | 2022-07-15 |
| 71566 | ORIG | 2022-07-15 |
| 69805 | ORIG | 2022-01-03 |