Application 207752
- Type
- ANDA
- Sponsor
- BIOCON LTD
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 |
|---|---|---|---|---|---|
| 50090-5970 | Rosuvastatin calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 70377-006 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-006 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-006 | Rosuvastatin Calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-006 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-006 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-007 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-007 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-007 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-007 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-007 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-008 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-008 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-008 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-008 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-008 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-009 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-009 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-009 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-009 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70377-009 | Rosuvastatin calcium | Rosuvastatin Calcium | Biocon Pharma Inc | ANDA | Current |
| 70518-1745 | Rosuvastatin calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1745 | Rosuvastatin calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 71205-052 | Rosuvastatin calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 71205-052 | Rosuvastatin calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 71205-052 | Rosuvastatin calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 71335-1741 | Rosuvastatin calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1741 | Rosuvastatin calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1889 | Rosuvastatin calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1889 | Rosuvastatin calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1890 | Rosuvastatin calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1890 | Rosuvastatin calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1939 | Rosuvastatin calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1939 | Rosuvastatin calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71610-133 | Rosuvastatin calcium | Rosuvastatin Calcium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |