FDA.reportPublic FDA data

Application 075037

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET;ORAL20MGNoNo
002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2620Isosorbide MononitrateIsosorbide MononitrateActavis Pharma, Inc.ANDACurrent
0228-2620Isosorbide MononitrateIsosorbide MononitrateActavis Pharma, Inc.ANDACurrent
0228-2620Isosorbide MononitrateIsosorbide MononitrateActavis Pharma, Inc.ANDACurrent
0228-2631Isosorbide MononitrateIsosorbide MononitrateActavis Pharma, Inc.ANDACurrent
0228-2631Isosorbide MononitrateIsosorbide MononitrateActavis Pharma, Inc.ANDACurrent
0228-2631Isosorbide MononitrateIsosorbide MononitrateActavis Pharma, Inc.ANDACurrent
0615-5549Isosorbide MononitrateIsosorbide MononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5550Isosorbide MononitrateIsosorbide MononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
70518-1485Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-1485Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-1485Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-1485Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-1485Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-1485Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-3081Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30737ORIG1998-10-30