FDA.reportPublic FDA data

Application 209339

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
0363-0508Esomeprazole MagnesiumEsomeprazole MagnesiumWALGREEN CO.ANDACurrent
0363-0508Esomeprazole MagnesiumEsomeprazole MagnesiumWALGREEN CO.ANDACurrent
0363-0508Esomeprazole MagnesiumEsomeprazole MagnesiumWALGREEN CO.ANDACurrent
0363-0508Esomeprazole MagnesiumEsomeprazole MagnesiumWALGREEN CO.ANDACurrent
0363-0508Esomeprazole MagnesiumEsomeprazole MagnesiumWALGREEN CO.ANDACurrent
0363-0508Esomeprazole MagnesiumEsomeprazole MagnesiumWALGREEN CO.ANDACurrent
21130-100Esomeprazole MagnesiumEsomeprazole MagnesiumBetter Living Brands LLCANDACurrent
21130-100Esomeprazole MagnesiumEsomeprazole MagnesiumBetter Living Brands LLCANDACurrent
46122-538Esomeprazole MagnesiumEsomeprazole MagnesiumAmerisource BergenANDACurrent
46122-538Esomeprazole MagnesiumEsomeprazole MagnesiumAmerisource BergenANDACurrent
46122-538Esomeprazole MagnesiumEsomeprazole MagnesiumAmerisource BergenANDACurrent
46122-538Esomeprazole MagnesiumEsomeprazole MagnesiumAmerisource BergenANDACurrent
49035-980Esomeprazole MagnesiumEsomeprazole MagnesiumWal-Mart Stores, Inc.ANDACurrent
49035-980Esomeprazole MagnesiumEsomeprazole MagnesiumWal-Mart Stores, Inc.ANDACurrent
49035-980Esomeprazole MagnesiumEsomeprazole MagnesiumWal-Mart Stores, Inc.ANDACurrent
49035-980Esomeprazole MagnesiumEsomeprazole MagnesiumWal-Mart Stores, Inc.ANDACurrent
49035-980Esomeprazole MagnesiumEsomeprazole MagnesiumWal-Mart Stores, Inc.ANDACurrent
50066-923GENOZOLEsomeprazole MagnesiumGenomma Lab USA IncANDACurrent
50066-923GENOZOLEsomeprazole MagnesiumGenomma Lab USA IncANDACurrent
50066-923GENOZOLEsomeprazole MagnesiumGenomma Lab USA IncANDACurrent
50066-923GENOZOLEsomeprazole MagnesiumGenomma Lab USA IncANDACurrent
50066-923GENOZOLEsomeprazole MagnesiumGenomma Lab USA IncANDACurrent
53943-890Esomeprazole MagnesiumEsomeprazole MagnesiumDISCOUNT DRUG MARTANDACurrent
53943-890Esomeprazole MagnesiumEsomeprazole MagnesiumDISCOUNT DRUG MARTANDACurrent
53943-890Esomeprazole MagnesiumEsomeprazole MagnesiumDISCOUNT DRUG MARTANDACurrent
53943-890Esomeprazole MagnesiumEsomeprazole MagnesiumDISCOUNT DRUG MARTANDACurrent
55315-010Esomeprazole MagnesiumEsomeprazole MagnesiumFred's, Inc.ANDACurrent
55315-010Esomeprazole MagnesiumEsomeprazole MagnesiumFred's, Inc.ANDACurrent
55315-010Esomeprazole MagnesiumEsomeprazole MagnesiumFred's, Inc.ANDACurrent
55319-988Esomeprazole MagnesiumEsomeprazole MagnesiumFamily Dollar, Inc.ANDACurrent
55319-988Esomeprazole MagnesiumEsomeprazole MagnesiumFamily Dollar, Inc.ANDACurrent
55319-988Esomeprazole MagnesiumEsomeprazole MagnesiumFamily Dollar, Inc.ANDACurrent
55319-988Esomeprazole MagnesiumEsomeprazole MagnesiumFamily Dollar, Inc.ANDACurrent
55910-016Esomeprazole MagnesiumEsomeprazole MagnesiumDolgencorp, LLCANDACurrent
55910-016Esomeprazole MagnesiumEsomeprazole MagnesiumDolgencorp, LLCANDACurrent
55910-016Esomeprazole MagnesiumEsomeprazole MagnesiumDolgencorp, LLCANDACurrent
55910-016Esomeprazole MagnesiumEsomeprazole MagnesiumDolgencorp, LLCANDACurrent
56062-020Esomeprazole MagnesiumEsomeprazole MagnesiumPublixANDACurrent
56062-020Esomeprazole MagnesiumEsomeprazole MagnesiumPublixANDACurrent
56062-020Esomeprazole MagnesiumEsomeprazole MagnesiumPublixANDACurrent
58602-809Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-809Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-809Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-809Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-809Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-809Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-809Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-822Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-822Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-822Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-822Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-822Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-846Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-846Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
58602-846Esomeprazole MagnesiumEsomeprazole MagnesiumAurohealth LLCANDACurrent
60000-109Esomeprazole MagnesiumEsomeprazole MagnesiumAhold U.S.A., Inc,ANDACurrent
60000-109Esomeprazole MagnesiumEsomeprazole MagnesiumAhold U.S.A., Inc,ANDACurrent
60000-109Esomeprazole MagnesiumEsomeprazole MagnesiumAhold U.S.A., Inc,ANDACurrent
62011-0402Esomeprazole MagnesiumEsomeprazole MagnesiumMcKESSON CorporationANDACurrent
63941-971Esomeprazole MagnesiumEsomeprazole MagnesiumBest ChoiceANDACurrent
63941-971Esomeprazole MagnesiumEsomeprazole MagnesiumBest ChoiceANDACurrent
63941-971Esomeprazole MagnesiumEsomeprazole MagnesiumBest ChoiceANDACurrent
63941-971Esomeprazole MagnesiumEsomeprazole MagnesiumBest ChoiceANDACurrent
68016-007Esomeprazole MagnesiumEsomeprazole MagnesiumChain Drug Consortium, LLCANDACurrent
68016-007Esomeprazole MagnesiumEsomeprazole MagnesiumChain Drug Consortium, LLCANDACurrent
68016-007Esomeprazole MagnesiumEsomeprazole MagnesiumChain Drug Consortium, LLCANDACurrent
68016-007Esomeprazole MagnesiumEsomeprazole MagnesiumChain Drug Consortium, LLCANDACurrent
68196-977Esomeprazole MagnesiumEsomeprazole MagnesiumSam's West IncANDACurrent
68196-977Esomeprazole MagnesiumEsomeprazole MagnesiumSam's West IncANDACurrent
68196-977Esomeprazole MagnesiumEsomeprazole MagnesiumSam's West IncANDACurrent
68196-977Esomeprazole MagnesiumEsomeprazole MagnesiumSam's West IncANDACurrent
68196-977Esomeprazole MagnesiumEsomeprazole MagnesiumSam's West IncANDACurrent
69842-248Esomeprazole MagnesiumEsomeprazole MagnesiumCVS Pharmacy, Inc.ANDACurrent
69842-248Esomeprazole MagnesiumEsomeprazole MagnesiumCVS Pharmacy, Inc.ANDACurrent
69842-248Esomeprazole MagnesiumEsomeprazole MagnesiumCVS Pharmacy, Inc.ANDACurrent
69842-248Esomeprazole MagnesiumEsomeprazole MagnesiumCVS Pharmacy, Inc.ANDACurrent
69842-248Esomeprazole MagnesiumEsomeprazole MagnesiumCVS Pharmacy, Inc.ANDACurrent
70677-0069Esomeprazole MagnesiumEsomeprazole MagnesiumMcKESSON CorporationANDACurrent
72036-800Esomeprazole MagnesiumEsomeprazole MagnesiumHarris TeeterANDACurrent
72036-800Esomeprazole MagnesiumEsomeprazole MagnesiumHarris TeeterANDACurrent