FDA.reportPublic FDA data

Application 212928

Type
ANDA
Sponsor
TWI PHARMS

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
24979-085Propafenone HydrochloridepropafenoneTWi Pharmaceuticals, Inc.ANDACurrent
24979-086Propafenone HydrochloridepropafenoneTWi Pharmaceuticals, Inc.ANDACurrent
24979-087Propafenone HydrochloridepropafenoneTWi Pharmaceuticals, Inc.ANDACurrent
51407-477Propafenone HydrochloridepropafenoneGolden State Medical Supply, Inc.ANDACurrent
51407-478Propafenone HydrochloridepropafenoneGolden State Medical Supply, Inc.ANDACurrent
51407-479Propafenone HydrochloridepropafenoneGolden State Medical Supply, Inc.ANDACurrent
71205-940Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-940Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-941Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-941Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-942Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-942Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent