FDA.reportPublic FDA data

Application 075480

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL2.5MGNoNo
002ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL5MGNoNo
003ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL10MGNoNo
004ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1052Enalapril MaleateEnalapril MaleateMylan Pharmaceuticals Inc.ANDACurrent
0378-1052Enalapril MaleateEnalapril MaleateMylan Pharmaceuticals IncANDACurrent
0615-7907Enalapril MaleateEnalapril MaleateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7908Enalapril MaleateEnalapril MaleateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7909Enalapril MaleateEnalapril MaleateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-951Enalapril MaleateEnalapril MaleateMylan Institutional Inc.ANDACurrent
67046-157Enalapril MaleateEnalapril MaleateContract Pharmacy Services-PAANDACurrent
67046-158Enalapril MaleateEnalapril MaleateContract Pharmacy Services-PAANDACurrent
67046-159Enalapril MaleateEnalapril MaleateContract Pharmacy Services-PAANDACurrent
70518-0592Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.ANDACurrent
70518-0623Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8685ORIG2004-06-03
8684ORIG2000-08-22