Documents
Application Sponsors
| NDA 210875 | SUNOVION PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | FILM;SUBLINGUAL | 10MG | 2 | KYNMOBI | APOMORPHINE HYDROCHLORIDE |
| 002 | FILM;SUBLINGUAL | 15MG | 2 | KYNMOBI | APOMORPHINE HYDROCHLORIDE |
| 003 | FILM;SUBLINGUAL | 20MG | 2 | KYNMOBI | APOMORPHINE HYDROCHLORIDE |
| 004 | FILM;SUBLINGUAL | 25MG | 2 | KYNMOBI | APOMORPHINE HYDROCHLORIDE |
| 005 | FILM;SUBLINGUAL | 30MG | 2 | KYNMOBI | APOMORPHINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2020-05-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2022-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-05-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
TE Codes
| 001 | Prescription | TBD |
| 002 | Prescription | TBD |
| 003 | Prescription | TBD |
| 004 | Prescription | TBD |
| 005 | Prescription | TBD |
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
)
)