NDA 210933

KALA PHARMS INC

FDA Drug Application

Application #210933

Documents

• Label: 2020-10-30
• Letter: 2020-11-02
• Review: 2021-09-08

Application Sponsors

NDA 210933

KALA PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;OPHTHALMIC

0.25%

2

EYSUVIS

LOTEPREDNOL ETABONATE

FDA Submissions

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

ORIG

1

AP

2020-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

KALA PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210933
            [companyName] => KALA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EYSUVIS","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"0.25%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"10\/26\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210933s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/26\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210933s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210933Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-10-26
        )

)