ANNORA PHARMA FDA Approval ANDA 212365

ANDA 212365

ANNORA PHARMA

FDA Drug Application

Application #212365

Documents

Letter2021-02-02

Application Sponsors

ANDA 212365ANNORA PHARMA

Marketing Status

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

Application Products

001TABLET;ORAL10MG0EMPAGLIFLOZINEMPAGLIFLOZIN
002TABLET;ORAL25MG0EMPAGLIFLOZINEMPAGLIFLOZIN

FDA Submissions

UNKNOWN; ORIG1TA2021-01-28STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212365
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN","activeIngredients":"EMPAGLIFLOZIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212365Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-28
        )

)

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