FDA.reportPublic FDA data

Application 212744

Type
ANDA
Sponsor
UPSHER SMITH LABS

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
0832-0740Propafenone HydrochloridePropafenone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0740Propafenone HydrochloridePropafenone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0741Propafenone HydrochloridePropafenone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0741Propafenone HydrochloridePropafenone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0742Propafenone HydrochloridePropafenone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0742Propafenone HydrochloridePropafenone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent