DIURNAL LTD FDA Approval NDA 213876

NDA 213876

DIURNAL LTD

FDA Drug Application

Application #213876

Documents

Letter2020-09-30
Label2020-10-01

Application Sponsors

NDA 213876DIURNAL LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL0.5MG0ALKINDI SPRINKLEHYDROCORTISONE
002CAPSULE;ORAL1MG0ALKINDI SPRINKLEHYDROCORTISONE
003CAPSULE;ORAL2MG0ALKINDI SPRINKLEHYDROCORTISONE
004CAPSULE;ORAL5MG0ALKINDI SPRINKLEHYDROCORTISONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-09-29STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

DIURNAL LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213876
            [companyName] => DIURNAL LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALKINDI SPRINKLE","activeIngredients":"HYDROCORTISONE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALKINDI SPRINKLE","activeIngredients":"HYDROCORTISONE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALKINDI SPRINKLE","activeIngredients":"HYDROCORTISONE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALKINDI SPRINKLE","activeIngredients":"HYDROCORTISONE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/29\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213876s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213876s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213876Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-09-29
        )

)

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