PRINSTON PHARMA INC FDA Approval ANDA 210771

ANDA 210771

PRINSTON PHARMA INC

FDA Drug Application

Application #210771

Documents

Letter2022-09-07

Application Sponsors

ANDA 210771PRINSTON PHARMA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL20MG0LEVOMILNACIPRANLEVOMILNACIPRAN
002CAPSULE, EXTENDED RELEASE;ORAL40MG0LEVOMILNACIPRANLEVOMILNACIPRAN
003CAPSULE, EXTENDED RELEASE;ORAL80MG0LEVOMILNACIPRANLEVOMILNACIPRAN
004CAPSULE, EXTENDED RELEASE;ORAL120MG0LEVOMILNACIPRANLEVOMILNACIPRAN

FDA Submissions

UNKNOWN; ORIG1TA2022-08-17STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

PRINSTON PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210771
            [companyName] => PRINSTON PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOMILNACIPRAN","activeIngredients":"LEVOMILNACIPRAN","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN","activeIngredients":"LEVOMILNACIPRAN","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN","activeIngredients":"LEVOMILNACIPRAN","strength":"80MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN","activeIngredients":"LEVOMILNACIPRAN","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-17
        )

)

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