NDA 213072

ALTHERA LIFE SCIENCES, LLC.

FDA Drug Application

Application #213072

Documents

• Letter: 2021-03-24
• Label: 2021-03-25
• Review: 2021-10-25

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

ORIG

1

Null

6

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
        )

)