FDA.reportPublic FDA data

Application 078169

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 5MG BASENoNo
002ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 10MG BASENoNo
003ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7953EscitalopramEscitslopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7953EscitalopramEscitslopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7954EscitalopramEscitslopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7954EscitalopramEscitslopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7955EscitalopramEscitslopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7955EscitalopramEscitslopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50090-5703EscitalopramEscitslopramA-S Medication SolutionsANDACurrent
50090-5704EscitalopramEscitslopramA-S Medication SolutionsANDACurrent
50090-5705EscitalopramEscitslopramA-S Medication SolutionsANDACurrent
50090-5830EscitalopramEscitslopramA-S Medication SolutionsANDACurrent
50090-5831EscitalopramEscitslopramA-S Medication SolutionsANDACurrent
50090-5831EscitalopramEscitslopramA-S Medication SolutionsANDACurrent
63629-6425EscitalopramEscitslopramBryant Ranch PrepackANDACurrent
63629-6425EscitalopramEscitslopramBryant Ranch PrepackANDACurrent
68180-135EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-135EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-135EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-135EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-135EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-136EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-136EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-136EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-136EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-136EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-137EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-137EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-137EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-137EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
68180-137EscitalopramEscitslopramLupin Pharmaceuticals, Inc.ANDACurrent
70518-2362EscitalopramEscitslopramREMEDYREPACK INC.ANDACurrent
70518-2362EscitalopramEscitslopramREMEDYREPACK INC.ANDACurrent
70518-2362EscitalopramEscitslopramREMEDYREPACK INC.ANDACurrent
70518-2362EscitalopramEscitslopramREMEDYREPACK INC.ANDACurrent
70518-2521EscitalopramEscitslopramREMEDYREPACK INC.ANDACurrent