FDA.reportPublic FDA data

Application 212866

Type
ANDA
Sponsor
SUN PHARM

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
30142-989esomeprazoleesomeprazoleTHE KROGER COMPANYANDACurrent
30142-989esomeprazoleesomeprazoleTHE KROGER COMPANYANDACurrent
51316-715EsomeprazoleESOMEPRAZOLE MAGNESIUMCVSANDACurrent
51660-027Esomeprazoleesomeprazole magnesiumOhm Laboratories Inc.ANDACurrent
51660-027Esomeprazoleesomeprazole magnesiumOhm Laboratories Inc.ANDACurrent
57483-900Esomeprazoleesomeprazole magnesiumINNOVUS PHARMACEUTICALS, INC.ANDACurrent
57483-900Esomeprazoleesomeprazole magnesiumINNOVUS PHARMACEUTICALS, INC.ANDACurrent
63304-740EsomeprazoleEsomeprazoleSun Pharmaceutical Industries, Inc.ANDACurrent
72036-982EsomeprazoleEsomeprazole MagnesiumHARRIS TEETERANDACurrent
72036-982EsomeprazoleEsomeprazole MagnesiumHARRIS TEETERANDACurrent
72559-011Esomeprazole MagnesiumEsomeprazole MagnesiumLITTLE PHARMA, INC.ANDACurrent
72559-011Esomeprazole MagnesiumEsomeprazole MagnesiumLITTLE PHARMA, INC.ANDACurrent
72559-011Esomeprazole MagnesiumEsomeprazole MagnesiumLITTLE PHARMA, INC.ANDACurrent
72559-011Esomeprazole MagnesiumEsomeprazole MagnesiumLITTLE PHARMA, INC.ANDACurrent
72559-011Esomeprazole MagnesiumEsomeprazole MagnesiumLITTLE PHARMA, INC.ANDACurrent
72559-011Esomeprazole MagnesiumEsomeprazole MagnesiumLITTLE PHARMA, INC.ANDACurrent