FDA.reportPublic FDA data

Application 211977

Type
ANDA
Sponsor
HETERO LABS LTD III

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
31722-664Esomeprazole MagnesiumEsomeprazole MagnesiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-665Esomeprazole MagnesiumEsomeprazole MagnesiumCamber Pharmaceuticals, Inc.ANDACurrent
50090-6198Esomeprazole MagnesiumEsomeprazole MagnesiumA-S Medication SolutionsANDACurrent
68071-2590Esomeprazole MagnesiumEsomeprazole MagnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2649Esomeprazole MagnesiumEsomeprazole MagnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2782Esomeprazole MagnesiumEsomeprazole MagnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8131Esomeprazole MagnesiumEsomeprazole MagnesiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8160Esomeprazole MagnesiumEsomeprazole MagnesiumPreferred Pharmaceuticals, Inc.ANDACurrent
71335-2018Esomeprazole MagnesiumEsomeprazole MagnesiumBryant Ranch PrepackANDACurrent
71335-2040Esomeprazole MagnesiumEsomeprazole MagnesiumBryant Ranch PrepackANDACurrent
72189-318ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMDirect RxANDACurrent
72189-318ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMDirect RxANDACurrent
72189-381Esomeprazole DREsomeprazole DRDirect_RxANDACurrent