Application 213072
- Type
- NDA
- Sponsor
- ALTHERA LIFE SCIENCES, LLC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROSZET | ROSUVASTATIN CALCIUM; EZETIMIBE | TABLET; ORAL | 5MG/10MG | Yes | No |
| 002 | ROSZET | ROSUVASTATIN CALCIUM; EZETIMIBE | TABLET; ORAL | 10MG/10MG | Yes | No |
| 003 | ROSZET | ROSUVASTATIN CALCIUM; EZETIMIBE | TABLET;ORAL | 20MG/10MG | Yes | No |
| 004 | ROSZET | ROSUVASTATIN CALCIUM; EZETIMIBE | TABLET; ORAL | 40MG/10MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70661-001 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-001 | ROSZET | rosuvastatin and ezetimibe | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-001 | ROSZET | rosuvastatin and ezetimibe | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-002 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-002 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-002 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-003 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-003 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-003 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-004 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-004 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 70661-004 | ROSZET | (rosuvastatin and ezetimibe) | Althera Pharmaceuticals LLC | NDA | Current |
| 82120-125 | ROSUVASTATIN AND EZETIMIBE | rosuvastatin and ezetimibe | SCOV3 LLC | NDA AUTHORIZED GENERIC | Current |
| 82120-126 | ROSUVASTATIN AND EZETIMIBE | rosuvastatin and ezetimibe | SCOV3 LLC | NDA AUTHORIZED GENERIC | Current |
| 82120-127 | ROSUVASTATIN AND EZETIMIBE | rosuvastatin and ezetimibe | SCOV3 LLC | NDA AUTHORIZED GENERIC | Current |
| 82120-128 | ROSUVASTATIN AND EZETIMIBE | rosuvastatin and ezetimibe | SCOV3 LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79497 | SUPPL | 2024-08-29 |
| 79488 | SUPPL | 2024-08-27 |
| 69080 | ORIG | 2021-10-25 |
| 66877 | ORIG | 2021-03-25 |
| 66861 | ORIG | 2021-03-24 |