FDA.reportPublic FDA data

Application 090655

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0259Montelukast SodiumMontelukast SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0259Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0259Montelukast SodiumMontelukast SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0259Montelukast SodiumMontelukast SodiumWest-Ward PharmaceuticalsANDACurrent
0054-0259Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0259Montelukast SodiumMontelukast SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0259Montelukast SodiumMontelukast SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0615-7983Montelukast SodiumMontelukast SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31484ORIG2012-08-06