KINAPSE LIMITED FDA Approval ANDA 212354

ANDA 212354

KINAPSE LIMITED

FDA Drug Application

Application #212354

Documents

Letter2020-09-22

Application Sponsors

ANDA 212354KINAPSE LIMITED

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET; ORAL10MG/5MG0EMPAGLIFLOZIN; LINAGLIPTINEMPAGLIFLOZIN; LINAGLIPTIN
002TABLET;ORAL25MG/5MG0EMPAGLIFLOZIN; LINAGLIPTINEMPAGLIFLOZIN; LINAGLIPTIN

FDA Submissions

UNKNOWN; ORIG1TA2020-08-26STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

KINAPSE LIMITED
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(
    [0] => Array
        (
            [ApplNo] => 212354
            [companyName] => KINAPSE LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN; LINAGLIPTIN","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN","strength":"10MG\/5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EMPAGLIFLOZIN; LINAGLIPTIN","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN","strength":"25MG\/5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212354Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-26
        )

)

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