BLA 761146

ENDO GLOBAL AESTHETICS LTD

FDA Drug Application

Application #761146

Documents

• Label: 2020-07-07
• Letter: 2020-07-08
• Review: 2021-01-28

Application Sponsors

BLA 761146

ENDO GLOBAL AESTHETICS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION		0	QWO	COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES
002	SOLUTION;SUBCUTANEOUS	1.84MG/VIAL	0	QWO	COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES

FDA Submissions

TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated

ORIG

1

AP

2020-07-06

PRIORITY

Submissions Property Types

ORIG

1

Null

40

CDER Filings

ENDO GLOBAL AESTHETICS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761146
            [companyName] => ENDO GLOBAL AESTHETICS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"QWO","activeIngredients":"COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES","strength":"","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761146s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761146s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761146Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-06
        )

)