Application 207375
- Type
- ANDA
- Sponsor
- SHANDONG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 5MG | No | No |
| 002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 10MG | No | No |
| 003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 20MG | No | No |
| 004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 40MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42677-301 | Rosuvastatin Calcium | Rosuvastatin Calcium | Shandong New Time Pharmaceutical Co., Ltd. | ANDA | Current |
| 42677-302 | Rosuvastatin Calcium | Rosuvastatin Calcium | Shandong New Time Pharmaceutical Co., Ltd. | ANDA | Current |
| 81288-751 | Rosuvastatin Calcium | Rosuvastatin Calcium | EMC PHARMA, LLC | ANDA | Current |
| 81288-755 | Rosuvastatin Calcium | Rosuvastatin Calcium | EMC PHARMA, LLC | ANDA | Current |