FDA.reportPublic FDA data

Application 077069

Type
ANDA
Sponsor
MURTY PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDETABLET;ORAL200MGNoNo
002AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDETABLET;ORAL400MGNoNo
003AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42494-307Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-307Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-307Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-307Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-307Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-307Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-308Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-308Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-308Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-308Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-308Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-308Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-309Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-309Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-309Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-309Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-309Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
42494-309Amiodarone HClAmiodarone HydrochlorideCameron Pharmaceuticals, LLCANDACurrent
51862-154Amiodarone HClAmiodarone HydrochlorideMayne Pharma Inc.ANDACurrent
51862-154Amiodarone HClAmiodarone HydrochlorideMayne Pharma Inc.ANDACurrent
51862-155Amiodarone HClAmiodarone HydrochlorideMayne Pharma Inc.ANDACurrent
51862-155Amiodarone HClAmiodarone HydrochlorideMayne Pharma Inc.ANDACurrent
51862-156Amiodarone HClAmiodarone HydrochlorideMayne Pharma Inc.ANDACurrent
51862-156Amiodarone HClAmiodarone HydrochlorideMayne Pharma Inc.ANDACurrent
63629-2001Amiodarone HClAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2001Amiodarone HClAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2001Amiodarone HClAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2076Amiodarone HClAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2076Amiodarone HClAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2076Amiodarone HClAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent
63629-9294Amiodarone HClAmiodarone HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23855ORIG2005-07-28