Application Sponsors
| ANDA 207453 | CADILA PHARMS LTD | |
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 | 2016-11-23 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-03-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
CADILA PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 207453
[companyName] => CADILA PHARMS LTD
[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":"11\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/10\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/10\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/10\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-10
)
)