Application 210875

Type
NDA
Sponsor
SUNOVION PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KYNMOBIAPOMORPHINE HYDROCHLORIDEFILM;SUBLINGUAL10MGYesNo
002KYNMOBIAPOMORPHINE HYDROCHLORIDEFILM;SUBLINGUAL15MGYesNo
003KYNMOBIAPOMORPHINE HYDROCHLORIDEFILM;SUBLINGUAL20MGYesNo
004KYNMOBIAPOMORPHINE HYDROCHLORIDEFILM;SUBLINGUAL25MGYesNo
005KYNMOBIAPOMORPHINE HYDROCHLORIDEFILM;SUBLINGUAL30MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63402-010KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-010KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-010KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-010KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-010KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-010KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-015KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-015KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-015KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-015KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-015KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-015KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-020KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-020KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-020KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-020KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-020KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-020KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-025KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-025KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-025KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-025KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-025KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-025KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-030KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-030KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-030KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-030KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-030KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-030KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-088KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-088KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-088KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-088KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-088KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-088KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-110KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-110KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-110KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-110KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-110KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-110KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-115KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-115KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-115KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-115KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-115KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-115KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-120KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-120KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-120KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-120KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-120KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-120KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-125KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-125KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-125KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-125KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-125KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-125KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-130KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-130KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-130KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-130KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-130KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-130KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-188KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-188KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-188KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-188KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-188KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent
63402-188KYNMOBIapomorphine hydrochlorideSunovion Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72149SUPPL2022-09-23
72144SUPPL2022-09-23
71022SUPPL2022-05-06
71007SUPPL2022-05-06
64831ORIG2020-10-06
63317ORIG2020-05-28
63250ORIG2020-05-21