NDA 214965

SANTEN

FDA Drug Application

Application #214965

Documents

• Letter: 2021-06-24
• Label: 2021-06-28
• Review: 2022-05-04

Application Sponsors

NDA 214965

SANTEN

Marketing Status

• Prescription: 001

Application Products

001

EMULSION; OPHTHALMIC

0.1%

2

VERKAZIA

CYCLOSPORINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-06-23

STANDARD

Submissions Property Types

ORIG

1

Null

6

TE Codes

001

Prescription

TBD

CDER Filings

SANTEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214965
            [companyName] => SANTEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERKAZIA","activeIngredients":"CYCLOSPORINE","strength":"0.1%","dosageForm":"EMULSION; OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214965Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-23
        )

)