Application 209495

Type
ANDA
Sponsor
GLENMARK PHARMS

Related Records

Application Products

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

NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-6128Esomeprazole MagnesiumEsomeprazole MagnesiumA-S Medication SolutionsANDACurrent
50090-6213Esomeprazole MagnesiumEsomeprazole MagnesiumA-S Medication SolutionsANDACurrent
68462-390Esomeprazole MagnesiumEsomeprazole MagnesiumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-390Esomeprazole MagnesiumEsomeprazole MagnesiumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-391Esomeprazole MagnesiumEsomeprazole MagnesiumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-391Esomeprazole MagnesiumEsomeprazole MagnesiumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-557Esomeprazole MagnesiumEsomeprazole MagnesiumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-557Esomeprazole MagnesiumEsomeprazole MagnesiumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-558Esomeprazole MagnesiumEsomeprazole MagnesiumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-558Esomeprazole MagnesiumEsomeprazole MagnesiumGlenmark Pharmaceuticals Inc., USAANDACurrent