ALTHERA LIFE SCIENCES, LLC. FDA Approval NDA 213072

NDA 213072

ALTHERA LIFE SCIENCES, LLC.

FDA Drug Application

Application #213072

Documents

Letter2021-03-24
Label2021-03-25

Application Sponsors

NDA 213072ALTHERA LIFE SCIENCES, LLC.

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET; ORAL5MG/10MG2ROSZETROSUVASTATIN CALCIUM; EZETIMIBE
002TABLET; ORAL10MG/10MG2ROSZETROSUVASTATIN CALCIUM; EZETIMIBE
003TABLET;ORAL20MG/10MG2ROSZETROSUVASTATIN CALCIUM; EZETIMIBE
004TABLET; ORAL40MG/10MG2ROSZETROSUVASTATIN CALCIUM; EZETIMIBE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2021-03-23STANDARD

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD
002PrescriptionTBD
003PrescriptionTBD
004PrescriptionTBD

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
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.