FDA.reportPublic FDA data

Application 076362

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDETABLET;ORAL400MGNoNo
002AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-139Amiodarone HydrochlorideAmiodarone HydrochlorideAvKARE, Inc.ANDACurrent
51672-4056Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4056Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4056Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4056Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4057Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4057Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4057Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4057Amiodarone HydrochlorideAmiodarone HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23821ORIG2005-07-28