FDA.reportPublic FDA data

Application 214184

Type
ANDA
Sponsor
ZYDUS

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
68382-522Propafenone HydrochloridePropafenone HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-523Propafenone HydrochloridePropafenone HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-524Propafenone HydrochloridePropafenone HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1525Propafenone HydrochloridePropafenone HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1526Propafenone HydrochloridePropafenone HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1527Propafenone HydrochloridePropafenone HydrochlorideCadila Healthcare LimitedANDACurrent