Application 206084
- Type
- ANDA
- Sponsor
- SCOV3
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EZETIMIBE AND ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM; EZETIMIBE | TABLET;ORAL | EQ 10MG BASE;10MG | No | No |
| 002 | EZETIMIBE AND ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM; EZETIMIBE | TABLET;ORAL | EQ 20MG BASE;10MG | No | No |
| 003 | EZETIMIBE AND ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM; EZETIMIBE | TABLET;ORAL | EQ 40MG BASE;10MG | No | No |
| 004 | EZETIMIBE AND ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM; EZETIMIBE | TABLET;ORAL | EQ 80MG BASE;10MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70661-005 | LYPQOZET | (ezetimibe and atorvastatin) | Althera Pharmaceuticals, LLC | ANDA | Current |
| 70661-006 | LYPQOZET | (ezetimibe and atorvastatin) | Althera Pharmaceuticals, LLC | ANDA | Current |
| 70661-007 | LYPQOZET | (ezetimibe and atorvastatin) | Althera Pharmaceuticals, LLC | ANDA | Current |
| 70661-008 | LYPQOZET | (ezetimibe and atorvastatin) | Althera Pharmaceuticals, LLC | ANDA | Current |
| 82120-125 | ROSUVASTATIN AND EZETIMIBE | rosuvastatin and ezetimibe | SCOV3 LLC | ANDA | Current |
| 82120-126 | ROSUVASTATIN AND EZETIMIBE | rosuvastatin and ezetimibe | SCOV3 LLC | ANDA | Current |
| 82120-127 | ROSUVASTATIN AND EZETIMIBE | rosuvastatin and ezetimibe | SCOV3 LLC | ANDA | Current |
| 82120-128 | ROSUVASTATIN AND EZETIMIBE | rosuvastatin and ezetimibe | SCOV3 LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48206 | ORIG | 2017-05-02 |