FDA.reportPublic FDA data

Application 075395

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL30MGNoNo
002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL60MGNoNo
003ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8043ISOSORBIDE MONONITRATEisosorbide mononitrateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8043ISOSORBIDE MONONITRATEisosorbide mononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8043ISOSORBIDE MONONITRATEisosorbide mononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8043ISOSORBIDE MONONITRATEisosorbide mononitrateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8044ISOSORBIDE MONONITRATEisosorbide mononitrateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8044ISOSORBIDE MONONITRATEisosorbide mononitrateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8044ISOSORBIDE MONONITRATEisosorbide mononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8044ISOSORBIDE MONONITRATEisosorbide mononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
68382-650ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-650ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-650ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-650ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-651ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-651ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-651ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-651ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-652ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-652ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-652ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-652ISOSORBIDE MONONITRATEisosorbide mononitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70518-0214ISOSORBIDE MONONITRATEisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70518-0214ISOSORBIDE MONONITRATEisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70518-0214ISOSORBIDE MONONITRATEisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70518-0214ISOSORBIDE MONONITRATEisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70518-1080ISOSORBIDE MONONITRATEisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70518-1080ISOSORBIDE MONONITRATEisosorbide mononitrateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8646ORIG2000-03-16