TEVA PHARMS FDA Approval NDA 216774

NDA 216774

TEVA PHARMS

FDA Drug Application

Application #216774

Documents

Letter2022-10-04

Application Sponsors

NDA 216774TEVA PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET; ORAL9MG0ALVAIZELTROMBOPAG
002TABLET; ORAL18MG0ALVAIZELTROMBOPAG
003TABLET; ORAL36MG0ALVAIZELTROMBOPAG
004TABLET;ORAL54MG0ALVAIZELTROMBOPAG

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1TA2022-10-03STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

TEVA PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216774
            [companyName] => TEVA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALVAIZ","activeIngredients":"ELTROMBOPAG","strength":"9MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALVAIZ","activeIngredients":"ELTROMBOPAG","strength":"18MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALVAIZ","activeIngredients":"ELTROMBOPAG","strength":"36MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALVAIZ","activeIngredients":"ELTROMBOPAG","strength":"54MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/03\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216774Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-03
        )

)

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