FDA.reportPublic FDA data

Application 205268

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

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
16714-825propafenone hydrochloridepropafenone hydrochlorideNorthstar Rx LLCANDACurrent
16714-825propafenone hydrochloridepropafenone hydrochlorideNorthstar Rx LLCANDACurrent
16714-826propafenone hydrochloridepropafenone hydrochlorideNorthstar Rx LLCANDACurrent
16714-826propafenone hydrochloridepropafenone hydrochlorideNorthstar Rx LLCANDACurrent
16714-827propafenone hydrochloridepropafenone hydrochlorideNorthstar Rx LLCANDACurrent
16714-827propafenone hydrochloridepropafenone hydrochlorideNorthstar Rx LLCANDACurrent
68462-408propafenone hydrochloridepropafenone hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-408propafenone hydrochloridepropafenone hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-409propafenone hydrochloridepropafenone hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-409propafenone hydrochloridepropafenone hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-410propafenone hydrochloridepropafenone hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-410propafenone hydrochloridepropafenone hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent