ANDA 207606

APOTEX

FDA Drug Application

Application #207606

Application Sponsors

ANDA 207606

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

EMULSION;OPHTHALMIC

0.05%

0

CYCLOSPORINE

CYCLOSPORINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-12

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207606
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"0.05%","dosageForm":"EMULSION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/12\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-12
        )

)