Application Sponsors
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
N/A; Not Applicable | ORIG | 1 | AP | 2016-10-31 | |
LABELING; Labeling | SUPPL | 2 | AP | 2020-03-09 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2020-03-09 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 201619
[companyName] => TORRENT
[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":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/09\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/09\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-09
)
)