FDA.reportPublic FDA data

Application 077522

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANDOLAPRILTRANDOLAPRILTABLET;ORAL1MGNoNo
002TRANDOLAPRILTRANDOLAPRILTABLET;ORAL2MGNoNo
003TRANDOLAPRILTRANDOLAPRILTABLET;ORAL4MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4128TrandolaprilTrandolaprilA-S Medication SolutionsANDACurrent
50090-4128TrandolaprilTrandolaprilA-S Medication SolutionsANDACurrent
63629-8003TrandolaprilTrandolaprilBryant Ranch PrepackANDACurrent
63629-8003TrandolaprilTrandolaprilBryant Ranch PrepackANDACurrent
63629-8003TrandolaprilTrandolaprilBryant Ranch PrepackANDACurrent
68151-0757TrandolaprilTrandolaprilCarilion Materials ManagementANDACurrent
68180-566TrandolaprilTrandolaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-566TrandolaprilTrandolaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-566TrandolaprilTrandolaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-567TrandolaprilTrandolaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-567TrandolaprilTrandolaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-567TrandolaprilTrandolaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-568TrandolaprilTrandolaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-568TrandolaprilTrandolaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-568TrandolaprilTrandolaprilLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44354ORIG2007-06-18