Skip to contentApplication 079168
- Type
- ANDA
- Sponsor
- ALLIED
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 |
|---|
| 49884-260 | Rosuvastatin Calcium | rosuvastatin calcium | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-260 | Rosuvastatin Calcium | rosuvastatin calcium | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-261 | Rosuvastatin Calcium | rosuvastatin calcium | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-261 | Rosuvastatin Calcium | rosuvastatin calcium | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-262 | Rosuvastatin Calcium | rosuvastatin calcium | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-262 | Rosuvastatin Calcium | rosuvastatin calcium | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-263 | Rosuvastatin Calcium | rosuvastatin calcium | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-263 | Rosuvastatin Calcium | rosuvastatin calcium | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31420 | ORIG | 2016-07-20 |