FDA.reportPublic FDA data

Application 212088

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9977Acid ReducerEsomeprazole magnesiumWalgreensANDACurrent
11822-5600Acid ReducerEsomeprazole magnesiumRite Aid CorporationANDACurrent
11822-5600Acid ReducerEsomeprazole magnesiumRite Aid CorporationANDACurrent
11822-5600Acid ReducerEsomeprazole magnesiumRite Aid CorporationANDACurrent
37808-856Acid ReducerEsomeprazole magnesiumH E BANDACurrent
59726-056Acid ReducerEsomeprazole magnesiumP & L Development, LLCANDACurrent
59726-056Acid ReducerEsomeprazole magnesiumP & L Development, LLCANDACurrent
69842-679Acid ReducerEsomeprazole magnesiumCVS PharmacyANDACurrent
69842-679Acid ReducerEsomeprazole magnesiumCVS PharmacyANDACurrent
70000-0095Acid ReducerEsomeprazole magnesiumCardinal Health (Leader) 70000ANDACurrent
70000-0095Acid ReducerEsomeprazole magnesiumCardinal Health (Leader) 70000ANDACurrent
70000-0095Acid ReducerEsomeprazole magnesiumCardinal Health (Leader) 70000ANDACurrent