FDA.reportPublic FDA data

Application 206296

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
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#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60760-246esomeprazole magnesiumesomeprazole magnesiumSt. Mary's Medical Park PharmacyANDACurrent
68071-5117esomeprazole magnesiumesomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5117esomeprazole magnesiumesomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68382-441esomeprazole magnesiumesomeprazole magnesiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-441esomeprazole magnesiumesomeprazole magnesiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-441esomeprazole magnesiumesomeprazole magnesiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-441esomeprazole magnesiumesomeprazole magnesiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-442esomeprazole magnesiumesomeprazole magnesiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-442esomeprazole magnesiumesomeprazole magnesiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-442esomeprazole magnesiumesomeprazole magnesiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-442esomeprazole magnesiumesomeprazole magnesiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7591esomeprazole magnesiumesomeprazole magnesiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7615esomeprazole magnesiumesomeprazole magnesiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7615esomeprazole magnesiumesomeprazole magnesiumPreferred Pharmaceuticals Inc.ANDACurrent
70771-1493esomeprazole magnesiumesomeprazole magnesiumZydus Lifesciences LimitedANDACurrent
70771-1493esomeprazole magnesiumesomeprazole magnesiumCadila Healthcare LimitedANDACurrent
70771-1493esomeprazole magnesiumesomeprazole magnesiumCadila Healthcare LimitedANDACurrent
70771-1494esomeprazole magnesiumesomeprazole magnesiumZydus Lifesciences LimitedANDACurrent
70771-1494esomeprazole magnesiumesomeprazole magnesiumCadila Healthcare LimitedANDACurrent
70771-1494esomeprazole magnesiumesomeprazole magnesiumCadila Healthcare LimitedANDACurrent
71335-1335esomeprazole magnesiumesomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-1335esomeprazole magnesiumesomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-1335esomeprazole magnesiumesomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-1368esomeprazole magnesiumesomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-1368esomeprazole magnesiumesomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-1368esomeprazole magnesiumesomeprazole magnesiumBryant Ranch PrepackANDACurrent