CIPLA LTD FDA Approval ANDA 210812

ANDA 210812

CIPLA LTD

FDA Drug Application

Application #210812

Documents

Letter2021-06-15

Application Sponsors

ANDA 210812CIPLA LTD

Marketing Status

None (Tentative Approval)001

Application Products

001UNKNOWNUNKNOWN0DOLUTEGRAVIR SODIUMDOLUTEGRAVIR SODIUM

FDA Submissions

UNKNOWN; ORIG1TA2021-05-18STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

CIPLA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210812
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR SODIUM","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-18
        )

)

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