CLEARSIDE BIOMEDICAL, INC FDA Approval NDA 211950

NDA 211950

CLEARSIDE BIOMEDICAL, INC

FDA Drug Application

Application #211950

Documents

Label2021-10-25
Letter2021-10-25

Application Sponsors

NDA 211950CLEARSIDE BIOMEDICAL, INC

Marketing Status

Prescription001

Application Products

001INJECTABLE; SUSPENSION40MG/ML0XIPERETRIAMCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-10-22STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

CLEARSIDE BIOMEDICAL, INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211950
            [companyName] => CLEARSIDE BIOMEDICAL, INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"XIPERE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"40MG\/ML","dosageForm":"INJECTABLE; SUSPENSION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211950s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211950s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"httpS:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211950Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-22
        )

)

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