NDA 211950

CLEARSIDE BIOMEDICAL, INC

FDA Drug Application

Application #211950

Documents

• Label: 2021-10-25
• Letter: 2021-10-25
• Review: 2022-10-04

Application Sponsors

NDA 211950

CLEARSIDE BIOMEDICAL, INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; SUSPENSION

40MG/ML

0

XIPERE

TRIAMCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2021-10-22

STANDARD

Submissions Property Types

ORIG

1

Null

6

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
        )

)