FDA.reportPublic FDA data

Application 209716

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59726-912Esomeprazole MagnesiumEsomeprazole magnesiumP & L Development, LLCANDACurrent
69238-1050Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals NY LLCANDACurrent
69238-1050Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals NY LLCANDACurrent
69238-1050Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals NY LLCANDACurrent
69238-1050Esomeprazole MagnesiumEsomeprazole MagnesiumAmneal Pharmaceuticals NY LLCANDACurrent