AZURITY FDA Approval NDA 214679

NDA 214679

AZURITY

FDA Drug Application

Application #214679

Documents

Letter2021-11-08
Label2021-11-10

Application Sponsors

NDA 214679AZURITY

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001SOLUTION; ORAL15MG0EPRONTIATOPIRAMATE
002SOLUTION; ORAL25MG0EPRONTIATOPIRAMATE
003SOLUTION; ORAL50MG0EPRONTIATOPIRAMATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-11-05STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

AZURITY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214679
            [companyName] => AZURITY
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPRONTIA","activeIngredients":"TOPIRAMATE","strength":"15MG","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"EPRONTIA","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"EPRONTIA","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/05\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214679s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/05\/2021","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\\\/2021\\\/214679s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214679Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-05
        )

)

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