FDA.reportPublic FDA data

Application 209647

Type
ANDA
Sponsor
AMNEAL PHARMS NY

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
65162-644Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-644Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-644Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-644Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-644Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-644Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-644Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-645Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-645Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-645Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-645Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-645Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-645Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent
65162-645Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals LLCANDACurrent