SUNOVION PHARMS INC FDA Approval NDA 210875

NDA 210875

SUNOVION PHARMS INC

FDA Drug Application

Application #210875

Documents

Label2020-05-21
Letter2020-05-28

Application Sponsors

NDA 210875SUNOVION PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001FILM;SUBLINGUAL10MG2KYNMOBIAPOMORPHINE HYDROCHLORIDE
002FILM;SUBLINGUAL15MG2KYNMOBIAPOMORPHINE HYDROCHLORIDE
003FILM;SUBLINGUAL20MG2KYNMOBIAPOMORPHINE HYDROCHLORIDE
004FILM;SUBLINGUAL25MG2KYNMOBIAPOMORPHINE HYDROCHLORIDE
005FILM;SUBLINGUAL30MG2KYNMOBIAPOMORPHINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-05-21STANDARD

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD
002PrescriptionTBD
003PrescriptionTBD
004PrescriptionTBD
005PrescriptionTBD

CDER Filings

SUNOVION PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210875
            [companyName] => SUNOVION PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KYNMOBI","activeIngredients":"APOMORPHINE HYDROCHLORIDE","strength":"10MG","dosageForm":"FILM;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KYNMOBI","activeIngredients":"APOMORPHINE HYDROCHLORIDE","strength":"15MG","dosageForm":"FILM;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KYNMOBI","activeIngredients":"APOMORPHINE HYDROCHLORIDE","strength":"20MG","dosageForm":"FILM;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KYNMOBI","activeIngredients":"APOMORPHINE HYDROCHLORIDE","strength":"25MG","dosageForm":"FILM;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KYNMOBI","activeIngredients":"APOMORPHINE HYDROCHLORIDE","strength":"30MG","dosageForm":"FILM;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/21\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210875lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210875lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210875Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-21
        )

)

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