FDA.reportPublic FDA data

Application 204550

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-180Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-180Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-181Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-181Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-182Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-182Amiodarone HydrochlorideAmiodarone HydrochlorideAuroMedics Pharma LLCANDACurrent
71872-7149Amiodarone HydrochlorideAmiodarone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent