GLOBAL BLOOD THERAPS FDA Approval NDA 216157

NDA 216157

GLOBAL BLOOD THERAPS

FDA Drug Application

Application #216157

Documents

Label2021-12-19
Letter2021-12-15

Application Sponsors

NDA 216157GLOBAL BLOOD THERAPS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET; ORAL SUSPENSION300MG0OXBRYTAVOXELOTOR
002TABLET;ORAL500MG0OXBRYTAVOXELOTOR

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-12-17PRIORITY

Submissions Property Types

ORIG1Null15

CDER Filings

GLOBAL BLOOD THERAPS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216157
            [companyName] => GLOBAL BLOOD THERAPS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXBRYTA","activeIngredients":"VOXELOTOR","strength":"300MG","dosageForm":"TABLET; ORAL SUSPENSION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"OXBRYTA","activeIngredients":"VOXELOTOR","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/216157s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/216157s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/216157Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-17
        )

)

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