BLA 761192

MEDIWOUND, LTD

FDA Drug Application

Application #761192

Documents

• Letter: 2022-12-29
• Label: 2023-01-04

Application Sponsors

BLA 761192

MEDIWOUND, LTD

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

8.8%

0

NEXOBRID

ANACAULASE-BCDB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-12-28

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MEDIWOUND, LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761192
            [companyName] => MEDIWOUND, LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEXOBRID","activeIngredients":"ANACAULASE-BCDB","strength":"8.8%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/28\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/761192s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/761192s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2023\\\/761192Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-12-28
        )

)