Documents
Application Sponsors
ANDA 079167 | WATSON LABS INC | |
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
| ORIG | 1 | AP | 2016-04-29 | |
LABELING; Labeling | SUPPL | 4 | AP | 2016-09-06 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 79167
[companyName] => WATSON LABS INC
[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] => [{"actionDate":"04\/29\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/079167Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ROSUVASTATIN CALCIUM","submission":"ROSUVASTATIN CALCIUM","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROSUVASTATIN CALCIUM","submission":"ROSUVASTATIN CALCIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROSUVASTATIN CALCIUM","submission":"ROSUVASTATIN CALCIUM","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROSUVASTATIN CALCIUM","submission":"ROSUVASTATIN CALCIUM","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2016-04-29
)
)