FDA.reportPublic FDA data

Application 210593

Type
ANDA
Sponsor
SPIL

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9980OmeprazoleOMEPRAZOLE MAGNESIUMWalgreen CompanyANDACurrent
0363-9980OmeprazoleOMEPRAZOLE MAGNESIUMWalgreen CompanyANDACurrent
11673-948OmeprazoleOmeprazole MagnesiumUP & UPANDACurrent
11822-0061omeprazoleomeprazoleRite AidANDACurrent
11822-0061omeprazoleomeprazoleRite AidANDACurrent
46122-686OMEPRAZOLEOMEPRAZOLEAMERISOURCE BERGENANDACurrent
51316-061OmeprazoleOmeprazoleCVS Pharamacy, IncANDACurrent
51660-061OmeprazoleOmeprazoleOhm Laboratories Inc.ANDACurrent
51660-061OmeprazoleOmeprazoleOhm Laboratories Inc.ANDACurrent
57483-740omeprazoleomeprazoleINNOVUS PHARMACEUTICALS, INC.ANDACurrent
72559-010OmeprazoleOmeprazoleCuristANDACurrent
72559-010OmeprazoleOmeprazoleLittle Pharma, Inc.ANDACurrent
72559-010OmeprazoleOmeprazoleLittle Pharma, Inc.ANDACurrent
72559-010OmeprazoleOmeprazoleCuristANDACurrent
79481-0061OmeprazoleOmeprazoleMeijer Distribution Inc.ANDACurrent