PRINSTON PHARMA INC FDA Approval ANDA 212264

ANDA 212264

PRINSTON PHARMA INC

FDA Drug Application

Application #212264

Documents

Letter2022-02-04

Application Sponsors

ANDA 212264PRINSTON PHARMA INC

Marketing Status

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

Application Products

002TABLET;ORAL25MG;5MG0EMPAGLIFLOZIN AND LINAGLIPTINEMPAGLIFLOZIN; LINAGLIPTIN

FDA Submissions

UNKNOWN; ORIG1TA2022-01-20STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

PRINSTON PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212264
            [companyName] => PRINSTON PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN AND LINAGLIPTIN","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN","strength":"10MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EMPAGLIFLOZIN AND LINAGLIPTIN","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN","strength":"25MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/20\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/212264Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-20
        )

)

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