CIPLA FDA Approval ANDA 211776

ANDA 211776

CIPLA

FDA Drug Application

Application #211776

Documents

Letter2021-09-02

Application Sponsors

ANDA 211776CIPLA

Marketing Status

Prescription001

Application Products

001EMULSION;OPHTHALMIC0.05%0DIFLUPREDNATEDIFLUPREDNATE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

CIPLA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211776
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIFLUPREDNATE","activeIngredients":"DIFLUPREDNATE","strength":"0.05%","dosageForm":"EMULSION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-09
        )

)

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