ANDA 205894

MYLAN

FDA Drug Application

Application #205894

Documents

• Letter: 2022-02-04

Application Sponsors

ANDA 205894

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

EMULSION;OPHTHALMIC

0.05%

0

CYCLOSPORINE

CYCLOSPORINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205894
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"0.05%","dosageForm":"EMULSION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/205894Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-02
        )

)