FDA.reportPublic FDA data

Application 091128

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 4MG BASENoNo
002MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0288Montelukast SodiumMontelukast SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0288Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0288Montelukast SodiumMontelukast SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0288Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0288Montelukast SodiumMontelukast SodiumWest-Ward PharmaceuticalsANDACurrent
0054-0288Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0288Montelukast SodiumMontelukast SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0288Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0289Montelukast SodiumMontelukast SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0289Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0289Montelukast SodiumMontelukast SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0289Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0289Montelukast SodiumMontelukast SodiumWest-Ward PharmaceuticalsANDACurrent
0054-0289Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0289Montelukast SodiumMontelukast SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0289Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9319ORIG2012-08-06