ZEALAND PHARMA AS FDA Approval NDA 214231

NDA 214231

ZEALAND PHARMA AS

FDA Drug Application

Application #214231

Documents

Label2021-03-22
Letter2021-03-23
Review2021-04-19

Application Sponsors

NDA 214231ZEALAND PHARMA AS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION0.6MG/0.6ML2ZEGALOGUEDASIGLUCAGON
002SOLUTION;SUBCUTANEOUSEQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)1ZEGALOGUE (AUTOINJECTOR)DASIGLUCAGON HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-03-22PRIORITY

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD

CDER Filings

ZEALAND PHARMA AS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214231
            [companyName] => ZEALAND PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZEGALOGUE","activeIngredients":"DASIGLUCAGON","strength":"0.6MG\/0.6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214231s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214231s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214231Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-03-22
        )

)

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