FDA.reportPublic FDA data

Application 205695

Type
ANDA
Sponsor
ANBISON LAB

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
60723-004Montelukast SodiumMontelukast SodiumHangzhou Minsheng Binjiang Pharmaceutical CO., Ltd.ANDACurrent
60723-005Montelukast SodiumMontelukast SodiumHangzhou Minsheng Binjiang Pharmaceutical CO., Ltd.ANDACurrent
70436-090Montelukast SodiumMontelukast SodiumSlate Run Pharmaceuticals, LLC.ANDACurrent
70436-090Montelukast SodiumMontelukast SodiumSlate Run Pharmaceuticals, LLC.ANDACurrent
70436-091Montelukast SodiumMontelukast SodiumSlate Run Pharmaceuticals, LLC.ANDACurrent
70436-091Montelukast SodiumMontelukast SodiumSlate Run Pharmaceuticals, LLC.ANDACurrent