REVANCE THERAPEUTICS, INC. FDA Approval BLA 761127

BLA 761127

REVANCE THERAPEUTICS, INC.

FDA Drug Application

Application #761127

Documents

Letter2022-09-08
Label2022-09-09
Medication Guide2022-09-09

Application Sponsors

BLA 761127REVANCE THERAPEUTICS, INC.

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS0.1ML0DAXXIFYdaxibotulinumtoixnA-lanm

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-09-07STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

REVANCE THERAPEUTICS, INC.
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    [0] => Array
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            [companyName] => REVANCE THERAPEUTICS, INC.
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761127s000lbl.pdf#page=14"]
            [products] => [{"drugName":"DAXXIFY","activeIngredients":"daxibotulinumtoixnA-lanm","strength":"0.1ML","dosageForm":"INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/07\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761127s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761127s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761127Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-07
        )

)

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