CIPLA LIMITED FDA Approval ANDA 214058

ANDA 214058

CIPLA LIMITED

FDA Drug Application

Application #214058

Documents

Letter2022-11-28

Application Sponsors

ANDA 214058CIPLA LIMITED

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2022-09-27STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

CIPLA LIMITED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214058
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE","activeIngredients":"EMTRICITABINE;RILPIVIRINE;TENOFOVIR ALAFENAMIDE","strength":"200MG;25MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-27
        )

)

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