COMMCAVE THERAPEUTICS SA FDA Approval NDA 212994

NDA 212994

COMMCAVE THERAPEUTICS SA

FDA Drug Application

Application #212994

Documents

Letter2021-03-04
Label2021-03-04
Medication Guide2021-03-04
Review2021-04-01

Application Sponsors

NDA 212994COMMCAVE THERAPEUTICS SA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL26.1MG/5.2MG2AZSTARYSSERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE
002CAPSULE;ORAL39.2MG/7.8MG2AZSTARYSSERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE
003CAPSULE;ORAL52.3MG/10.4MG2AZSTARYSSERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2021-03-02STANDARD

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD
002PrescriptionTBD
003PrescriptionTBD

CDER Filings

COMMCAVE THERAPEUTICS SA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212994
            [companyName] => COMMCAVE THERAPEUTICS SA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/212994s000lbl.pdf#page=26"]
            [products] => [{"drugName":"AZSTARYS","activeIngredients":"SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE","strength":"26.1MG\/5.2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"AZSTARYS","activeIngredients":"SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE","strength":"39.2MG\/7.8MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"AZSTARYS","activeIngredients":"SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE","strength":"52.3MG\/10.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"03\/02\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212994s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212994s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212994Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-03-02
        )

)

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