FDA.reportPublic FDA data

Application 205956

Type
ANDA
Sponsor
WILSHIRE PHARMS 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
16571-736PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDERising Pharma Holdings, Inc.ANDACurrent
16571-737PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDERising Pharma Holdings, Inc.ANDACurrent
16571-738PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDERising Pharma Holdings, Inc.ANDACurrent
52536-730PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEWilshire PharmaceuticalsANDACurrent
52536-730PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEWilshire PharmaceuticalsANDACurrent
52536-730PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEWilshire PharmaceuticalsANDACurrent
52536-733PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEWilshire PharmaceuticalsANDACurrent
52536-733PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEWilshire PharmaceuticalsANDACurrent
52536-733PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEWilshire PharmaceuticalsANDACurrent
52536-735PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEWilshire PharmaceuticalsANDACurrent
52536-735PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEWilshire PharmaceuticalsANDACurrent
52536-735PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEWilshire PharmaceuticalsANDACurrent