PRINSTON PHARMA INC FDA Approval ANDA 210133

ANDA 210133

PRINSTON PHARMA INC

FDA Drug Application

Application #210133

Application Sponsors

ANDA 210133PRINSTON PHARMA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

002TABLET; ORAL5mg0APIXABANAPIXABAN

FDA Submissions

UNKNOWN; ORIG1TA2022-04-12STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

PRINSTON PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210133
            [companyName] => PRINSTON PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"2.5mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"5mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-12
        )

)

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