FDA.reportPublic FDA data

Application 075424

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDETABLET;ORAL200MGNoNo
002AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6993Amiodarone HydrochlorideAmiodarone HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6993Amiodarone HydrochlorideAmiodarone HydrochlorideMajor PharmaceuticalsANDACurrent
42291-118Amiodarone HydrochlorideAmiodarone HydrochlorideAvKARE, Inc.ANDACurrent
50090-3496Amiodarone HydrochlorideAmiodarone HydrochlorideA-S Medication SolutionsANDACurrent
50090-3496Amiodarone HydrochlorideAmiodarone HydrochlorideA-S Medication SolutionsANDACurrent
51672-4025Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4025Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4025Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4025Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4055Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4055Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4055Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4055Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
55154-3365Amiodarone HydrochlorideAmiodarone HydrochlorideCardinal Health 107, LLCANDACurrent
55154-3365Amiodarone HydrochlorideAmiodarone HydrochlorideCardinal HealthANDACurrent
55154-3365Amiodarone HydrochlorideAmiodarone HydrochlorideCardinal HealthANDACurrent
71335-0881Amiodarone HydrochlorideAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0881Amiodarone HydrochlorideAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0881Amiodarone HydrochlorideAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44256ORIG2005-07-28
8666ORIG2001-03-30