Documents
Application Sponsors
NDA 213072 | ALTHERA LIFE SCIENCES, LLC. | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET; ORAL | 5MG/10MG | 2 | ROSZET | ROSUVASTATIN CALCIUM; EZETIMIBE |
002 | TABLET; ORAL | 10MG/10MG | 2 | ROSZET | ROSUVASTATIN CALCIUM; EZETIMIBE |
003 | TABLET;ORAL | 20MG/10MG | 2 | ROSZET | ROSUVASTATIN CALCIUM; EZETIMIBE |
004 | TABLET; ORAL | 40MG/10MG | 2 | ROSZET | ROSUVASTATIN CALCIUM; EZETIMIBE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2021-03-23 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | TBD |
002 | Prescription | TBD |
003 | Prescription | TBD |
004 | Prescription | TBD |
CDER Filings
ALTHERA LIFE SCIENCES, LLC.
cder:Array
(
[0] => Array
(
[ApplNo] => 213072
[companyName] => ALTHERA LIFE SCIENCES, LLC.
[docInserts] => ["",""]
[products] => [{"drugName":"ROSZET","activeIngredients":"ROSUVASTATIN CALCIUM; EZETIMIBE","strength":"5MG\/10MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"ROSZET","activeIngredients":"ROSUVASTATIN CALCIUM; EZETIMIBE","strength":"10MG\/10MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"ROSZET","activeIngredients":"ROSUVASTATIN CALCIUM; EZETIMIBE","strength":"20MG\/10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"ROSZET","activeIngredients":"ROSUVASTATIN CALCIUM; EZETIMIBE","strength":"40MG\/10MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"03\/23\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213072s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213072s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213072Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-03-23
)
)