FDA.reportPublic FDA data

Application 077234

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

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
0143-9875Amiodarone HydrochlorideAmiodarone HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9875Amiodarone HydrochlorideAmiodarone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
51662-1205AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1205AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1205AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1205AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-063AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-063AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
70518-1231Amiodarone HydrochlorideAmiodarone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1231Amiodarone HydrochlorideAmiodarone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1231Amiodarone HydrochlorideAmiodarone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1231Amiodarone HydrochlorideAmiodarone HydrochlorideREMEDYREPACK INC.ANDACurrent
71872-7000Amiodarone HydrochlorideAmiodarone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7000Amiodarone HydrochlorideAmiodarone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44346ORIG2008-02-28