FDA.reportPublic FDA data

Application 210339

Type
ANDA
Sponsor
SINOTHERAPEUTICS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL225MGNoNo
002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL325MGNoNo
003PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL425MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69680-130Propafenone HydrochloridepropafenoneVitruvias TherapeuticsANDACurrent
69680-130Propafenone HydrochloridepropafenoneVitruvias TherapeuticsANDACurrent
69680-131Propafenone HydrochloridepropafenoneVitruvias TherapeuticsANDACurrent
69680-131Propafenone HydrochloridepropafenoneVitruvias TherapeuticsANDACurrent
69680-132Propafenone HydrochloridepropafenoneVitruvias TherapeuticsANDACurrent
69680-132Propafenone HydrochloridepropafenoneVitruvias TherapeuticsANDACurrent