Skip to contentApplication 079167
- Type
- ANDA
- Sponsor
- WATSON LABS 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 |
|---|
| 0904-6602 | Rosuvastatin Calcium | Rosuvastatin calcium | Major Pharmaceuticals | ANDA | Current |
| 0904-6603 | Rosuvastatin Calcium | Rosuvastatin calcium | Major Pharmaceuticals | ANDA | Current |
| 0904-6604 | Rosuvastatin Calcium | Rosuvastatin calcium | Major Pharmaceuticals | ANDA | Current |
| 0904-6605 | Rosuvastatin Calcium | Rosuvastatin calcium | Major Pharmaceuticals | ANDA | Current |
| 50090-2805 | Rosuvastatin Calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 70518-0167 | Rosuvastatin Calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39567 | ORIG | 2016-05-03 |
| 31419 | ORIG | 2016-05-03 |