BLA 761085

EVOLUS INC

FDA Drug Application

Application #761085

Documents

• Label: 2019-02-04
• Medication Guide: 2019-02-04
• Letter: 2019-02-13
• Review: 2019-03-05
• Letter: 2019-07-15
• Label: 2019-07-15

Application Sponsors

BLA 761085

EVOLUS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100 UNITS

0

JEUVEAU

PRABOTULINUMTOXINA-XVFS

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2019-02-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

EVOLUS INC

cder:Array
(
    [0] => Array
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            [companyName] => EVOLUS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761085s000lbl.pdf#page=9"]
            [products] => [{"drugName":"JEUVEAU","activeIngredients":"PRABOTULINUMTOXINA-XVFS","strength":"100 UNITS","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/12\/2019","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761085s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761085s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761085s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761085Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761085Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/12\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761085s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761085Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-07-12
        )

)