JANSSEN PHARMACEUTICALS INC FDA Approval NDA 213498

NDA 213498

JANSSEN PHARMACEUTICALS INC

FDA Drug Application

Application #213498

Documents

Label2021-03-19
Medication Guide2021-03-19
Letter2021-03-19

Application Sponsors

NDA 213498JANSSEN PHARMACEUTICALS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007
Prescription008
Prescription009
Prescription010

Application Products

001TABLET;ORAL2MG2PONVORYPONESIMOD
002TABLET;ORAL3MG2PONVORYPONESIMOD
003TABLET;ORAL4MG2PONVORYPONESIMOD
004TABLET;ORAL5MG2PONVORYPONESIMOD
005TABLET;ORAL6MG2PONVORYPONESIMOD
006TABLET;ORAL7MG2PONVORYPONESIMOD
007TABLET;ORAL8MG2PONVORYPONESIMOD
008TABLET;ORAL9MG2PONVORYPONESIMOD
009TABLET;ORAL10MG2PONVORYPONESIMOD
010TABLET;ORAL20MG2PONVORYPONESIMOD

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-03-18STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

JANSSEN PHARMACEUTICALS INC
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            [ApplNo] => 213498
            [companyName] => JANSSEN PHARMACEUTICALS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/213498s000lbl.pdf#page=30"]
            [products] => [{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"7MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"9MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"03\/18\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213498s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213498s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213498Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-03-18
        )

)

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