Application 207653
- Type
- ANDA
- Sponsor
- INVENTIA HEALTHCARE PRIVATE LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | UNKNOWN | UNKNOWN | 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49252-061 | ROSUVASTATIN | rosuvastatin | Inventia Healthcare Limited | ANDA | Current |
| 49252-061 | ROSUVASTATIN | rosuvastatin | Inventia Healthcare Limited | ANDA | Current |
| 49252-062 | ROSUVASTATIN | rosuvastatin | Inventia Healthcare Limited | ANDA | Current |
| 49252-062 | ROSUVASTATIN | rosuvastatin | Inventia Healthcare Limited | ANDA | Current |
| 49252-063 | ROSUVASTATIN | rosuvastatin | Inventia Healthcare Limited | ANDA | Current |
| 49252-063 | ROSUVASTATIN | rosuvastatin | Inventia Healthcare Limited | ANDA | Current |
| 49252-064 | ROSUVASTATIN | rosuvastatin | Inventia Healthcare Limited | ANDA | Current |
| 49252-064 | ROSUVASTATIN | rosuvastatin | Inventia Healthcare Limited | ANDA | Current |