FDA.reportPublic FDA data

Application 075938

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDETABLET;ORAL150MGNoNo
002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDETABLET;ORAL225MGNoNo
003PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDETABLET;ORAL300MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-5448Propafenone HydrochloridePropafenone HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5448Propafenone HydrochloridePropafenone HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5448Propafenone HydrochloridePropafenone HydrochloridePar PharmaceuticalANDACurrent
0603-5448Propafenone HydrochloridePropafenone HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5449Propafenone HydrochloridePropafenone HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5449Propafenone HydrochloridePropafenone HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5449Propafenone HydrochloridePropafenone HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5449Propafenone HydrochloridePropafenone HydrochloridePar PharmaceuticalANDACurrent
0603-5450Propafenone HydrochloridePropafenone HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5450Propafenone HydrochloridePropafenone HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5450Propafenone HydrochloridePropafenone HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5450Propafenone HydrochloridePropafenone HydrochloridePar PharmaceuticalANDACurrent
0615-7574Propafenone HydrochloridePropafenone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50090-1134Propafenone HydrochloridePropafenone HydrochlorideA-S Medication SolutionsANDACurrent
50090-1134Propafenone HydrochloridePropafenone HydrochlorideA-S Medication SolutionsANDACurrent
60687-537Propafenone HydrochloridePropafenone HydrochlorideAmerican Health PackagingANDACurrent
60687-537Propafenone HydrochloridePropafenone HydrochlorideAmerican Health PackagingANDACurrent
60687-537Propafenone HydrochloridePropafenone HydrochlorideAmerican Health PackagingANDACurrent
60687-709Propafenone HydrochloridePropafenone HydrochlorideAmerican Health PackagingANDACurrent
63629-2265Propafenone HydrochloridePropafenone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2265Propafenone HydrochloridePropafenone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2266Propafenone HydrochloridePropafenone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2266Propafenone HydrochloridePropafenone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2267Propafenone HydrochloridePropafenone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2267Propafenone HydrochloridePropafenone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2268Propafenone HydrochloridePropafenone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2268Propafenone HydrochloridePropafenone HydrochlorideBryant Ranch PrepackANDACurrent
64380-163PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEStrides Pharma Science LimitedANDACurrent
64380-163PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEStrides Pharma Science LimitedANDACurrent
64380-164PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEStrides Pharma Science LimitedANDACurrent
64380-164PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEStrides Pharma Science LimitedANDACurrent
64380-165PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEStrides Pharma Science LimitedANDACurrent
64380-165PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEStrides Pharma Science LimitedANDACurrent