FDA.reportPublic FDA data

Application 075315

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDETABLET;ORAL200MGNoYes
002AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDETABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0144Amiodarone HydrochlorideAmiodarone HydrochlorideEon Labs, Inc.ANDACurrent
0245-0145PaceroneAmiodarone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-0145PaceroneAmiodarone HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0615-4545Amiodarone HydrochlorideAmiodarone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4545Amiodarone HydrochlorideAmiodarone HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
63739-387Amiodarone HydrochlorideAmiodarone HydrochlorideMcKesson CorporationANDACurrent
63739-387Amiodarone HydrochlorideAmiodarone HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44254ORIG2005-07-28
42978ORIG2003-08-04
30847SUPPL2000-06-30
8613SUPPL2000-06-30
30848SUPPL2000-04-12
8614SUPPL2000-04-12
8612ORIG1998-12-23