FDA.reportPublic FDA data

Application 078438

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANDOLAPRILTRANDOLAPRILTABLET;ORAL1MGNoNo
002TRANDOLAPRILTRANDOLAPRILTABLET;ORAL2MGNoNo
003TRANDOLAPRILTRANDOLAPRILTABLET;ORAL4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4120TrandolaprilTrandolaprilA-S Medication SolutionsANDACurrent
50090-4120TrandolaprilTrandolaprilA-S Medication SolutionsANDACurrent
57237-089TrandolaprilTrandolaprilRising Health, LLCANDACurrent
57237-089TrandolaprilTrandolaprilRising Health, LLCANDACurrent
57237-090TrandolaprilTrandolaprilRising Health, LLCANDACurrent
57237-090TrandolaprilTrandolaprilRising Health, LLCANDACurrent
57237-091TrandolaprilTrandolaprilRising Health, LLCANDACurrent
57237-091TrandolaprilTrandolaprilRising Health, LLCANDACurrent
63629-8390TrandolaprilTrandolaprilBryant Ranch PrepackANDACurrent
65862-164TrandolaprilTrandolaprilAurobindo Pharma LimitedANDACurrent
65862-164TrandolaprilTrandolaprilAurobindo Pharma LimitedANDACurrent
65862-164TrandolaprilTrandolaprilAurobindo Pharma LimitedANDACurrent
65862-165TrandolaprilTrandolaprilAurobindo Pharma LimitedANDACurrent
65862-165TrandolaprilTrandolaprilAurobindo Pharma LimitedANDACurrent
65862-165TrandolaprilTrandolaprilAurobindo Pharma LimitedANDACurrent
65862-166TrandolaprilTrandolaprilAurobindo Pharma LimitedANDACurrent
65862-166TrandolaprilTrandolaprilAurobindo Pharma LimitedANDACurrent
65862-166TrandolaprilTrandolaprilAurobindo Pharma LimitedANDACurrent
71335-1431TrandolaprilTrandolaprilBryant Ranch PrepackANDACurrent
71335-1431TrandolaprilTrandolaprilBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44383ORIG2007-06-18