Application 206381
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50228-116 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-116 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-116 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-117 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-117 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-117 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-118 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-118 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-118 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-119 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-119 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-119 | Rosuvastatin | Rosuvastatin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |