INVENTIA HEALTHCARE PRIVATE LTD FDA Approval ANDA 207653

ANDA 207653

INVENTIA HEALTHCARE PRIVATE LTD

FDA Drug Application

Application #207653

Application Sponsors

ANDA 207653INVENTIA HEALTHCARE PRIVATE LTD

Marketing Status

None (Tentative Approval)001

Application Products

001UNKNOWNUNKNOWN0ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM

FDA Submissions

UNKNOWN; ORIG1TA2020-08-12STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

INVENTIA HEALTHCARE PRIVATE LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207653
            [companyName] => INVENTIA HEALTHCARE PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-12
        )

)

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