Application Sponsors
| ANDA 206434 | ACCORD HLTHCARE | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM |
| 002 | TABLET;ORAL | 10MG | 0 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM |
| 003 | TABLET;ORAL | 20MG | 0 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM |
| 004 | TABLET;ORAL | 40MG | 0 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-03-12 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-03-12 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
ACCORD HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 206434
[companyName] => ACCORD HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/31\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/12\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/12\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-12
)
)