FDA.reportPublic FDA data

Application 205563

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASENoNo
002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-102Esomeprazole MagnesiumEsomeprazole MagnesiumMedsource PharmaceuticalsANDACurrent
50090-3846Esomeprazole MagnesiumEsomeprazole MagnesiumA-S Medication SolutionsANDACurrent
50090-3846Esomeprazole MagnesiumEsomeprazole MagnesiumA-S Medication SolutionsANDACurrent
50090-3903Esomeprazole MagnesiumEsomeprazole MagnesiumA-S Medication SolutionsANDACurrent
50090-3903Esomeprazole MagnesiumEsomeprazole MagnesiumA-S Medication SolutionsANDACurrent
50090-3903Esomeprazole MagnesiumEsomeprazole MagnesiumA-S Medication SolutionsANDACurrent
62175-820Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-820Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-820Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-820Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-820Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-820Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-840Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-840Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-840Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-840Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-840Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
62175-840Esomeprazole MagnesiumEsomeprazole MagnesiumLannett Company, Inc.ANDACurrent
68071-5074Esomeprazole MagnesiumEsomeprazole MagnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5074Esomeprazole MagnesiumEsomeprazole MagnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
71335-1170Esomeprazole MagnesiumEsomeprazole MagnesiumBryant Ranch PrepackANDACurrent
71335-1170Esomeprazole MagnesiumEsomeprazole MagnesiumBryant Ranch PrepackANDACurrent
71335-1170Esomeprazole MagnesiumEsomeprazole MagnesiumBryant Ranch PrepackANDACurrent
71335-1170Esomeprazole MagnesiumEsomeprazole MagnesiumBryant Ranch PrepackANDACurrent