BLA 761127

REVANCE THERAPEUTICS, INC.

FDA Drug Application

Application #761127

Documents

• Letter: 2022-09-08
• Label: 2022-09-09
• Medication Guide: 2022-09-09
• Review: 2022-10-06

Application Sponsors

BLA 761127

REVANCE THERAPEUTICS, INC.

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

0.1ML

0

DAXXIFY

daxibotulinumtoixnA-lanm

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-09-07

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

REVANCE THERAPEUTICS, INC.

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            [companyName] => REVANCE THERAPEUTICS, INC.
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            [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
        )

)