Application 079171
- Type
- ANDA
- Sponsor
- SANDOZ INC
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 |
|---|---|---|---|---|---|
| 0781-5400 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5400 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5400 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5401 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5401 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5401 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5402 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5402 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5402 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5403 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5403 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 0781-5403 | Rosuvastatin calcium | Rosuvastatin calcium | Sandoz Inc | ANDA | Current |
| 70518-0933 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0933 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0963 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0963 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 71205-077 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-077 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 76519-1162 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | H. J. Harkins Company Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9233 | ORIG | 2016-07-20 |