FDA.reportPublic FDA data

Application 205426

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVEROLIMUSEVEROLIMUSTABLET;ORAL2.5MGNoNo
002EVEROLIMUSEVEROLIMUSTABLET;ORAL5MGNoNo
003EVEROLIMUSEVEROLIMUSTABLET;ORAL7.5MGNoNo
004EVEROLIMUSEVEROLIMUSTABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-821EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-821EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-821EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-821EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-822EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-822EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-822EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-822EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-823EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-823EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-823EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-823EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-824EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-824EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-824EverolimusEverolimusBreckenridge Pharmaceutical, Inc.ANDACurrent
63850-0058EverolimusEverolimusNatco Pharma LimitedANDACurrent
63850-0058EverolimusEverolimusNatco Pharma LimitedANDACurrent
63850-0059EverolimusEverolimusNatco Pharma LimitedANDACurrent
63850-0059EverolimusEverolimusNatco Pharma LimitedANDACurrent
63850-0060EverolimusEverolimusNatco Pharma LimitedANDACurrent
63850-0060EverolimusEverolimusNatco Pharma LimitedANDACurrent
63850-0061EverolimusEverolimusNatco Pharma LimitedANDACurrent
63850-0061EverolimusEverolimusNatco Pharma LimitedANDACurrent