AZURITY FDA Approval NDA 214273

NDA 214273

AZURITY

FDA Drug Application

Application #214273

Documents

Label2022-07-18
Medication Guide2022-07-18
Letter2022-07-19

Application Sponsors

NDA 214273AZURITY

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL100MG/5ML0ZONISADEZONISAMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-07-15STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

AZURITY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214273
            [companyName] => AZURITY
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/214273s000lbl.pdf#page=27"]
            [products] => [{"drugName":"ZONISADE","activeIngredients":"ZONISAMIDE","strength":"100MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/15\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214273s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/15\/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\\\/214273s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214273Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-07-15
        )

)

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