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Application 079145
- Type
- ANDA
- Sponsor
- APOTEX 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 |
|---|
| 60505-2885 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-2886 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-2887 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-2888 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4502 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4502 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4502 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4502 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4502 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4503 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4503 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4503 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4503 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4503 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4504 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4504 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4504 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4504 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4504 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4505 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4505 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4505 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4505 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
| 60505-4505 | ROSUVASTATIN | ROSUVASTATIN CALCIUM | Apotex Corp. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9226 | ORIG | 2016-07-20 |