AZURITY FDA Approval NDA 215602

NDA 215602

AZURITY

FDA Drug Application

Application #215602

Documents

Letter2022-02-08
Label2022-02-08

Application Sponsors

NDA 215602AZURITY

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL25MG/5ML1FLEQSUVYBACLOFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-02-04STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

AZURITY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215602
            [companyName] => AZURITY
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLEQSUVY","activeIngredients":"BACLOFEN","strength":"25MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/04\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215602s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/04\/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\\\/215602s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215602Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-02-04
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.