CORIUM, INC. FDA Approval NDA 212304

NDA 212304

CORIUM, INC.

FDA Drug Application

Application #212304

Documents

Letter2022-03-14
Label2022-03-15

Application Sponsors

NDA 212304CORIUM, INC.

Marketing Status

Prescription001
Prescription002

Application Products

001SYSTEM;TRANSDERMAL5MG/24HR0ADLARITYDONEPEZIL HYDROCHLORIDE
002SYSTEM;TRANSDERMAL10MG/24HR0ADLARITYDONEPEZIL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-03-11STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

CORIUM, INC.
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212304
            [companyName] => CORIUM, INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADLARITY","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ADLARITY","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/11\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212304s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212304s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/212304Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-11
        )

)

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