FDA.reportPublic FDA data

Application 208333

Type
ANDA
Sponsor
ALKEM LABS LTD

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
61919-789ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMDirectRXANDACurrent
61919-789ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMDirectRXANDACurrent
61919-868ESOMEPRAZOLE MAGNEISUM D/RESOMEPRAZOLE MAGNEISUM D/RDirect_RxANDACurrent
67877-478Esomeprazole magnesiumEsomeprazole magnesiumAscend Laboratories, LLCANDACurrent
67877-478Esomeprazole magnesiumEsomeprazole magnesiumAscend Laboratories, LLCANDACurrent
67877-478Esomeprazole magnesiumEsomeprazole magnesiumAscend Laboratories, LLCANDACurrent
67877-479Esomeprazole magnesiumEsomeprazole magnesiumAscend Laboratories, LLCANDACurrent
67877-479Esomeprazole magnesiumEsomeprazole magnesiumAscend Laboratories, LLCANDACurrent
67877-479Esomeprazole magnesiumEsomeprazole magnesiumAscend Laboratories, LLCANDACurrent
68071-4886Esomeprazole magnesiumEsomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4886Esomeprazole magnesiumEsomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4888Esomeprazole magnesiumEsomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4888Esomeprazole magnesiumEsomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4936Esomeprazole magnesiumEsomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4936Esomeprazole magnesiumEsomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7442Esomeprazole magnesiumEsomeprazole magnesiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7442Esomeprazole magnesiumEsomeprazole magnesiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7483Esomeprazole magnesiumEsomeprazole magnesiumPreferred Pharmaceuticals Inc.ANDACurrent
71335-0987Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-0987Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-0987Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-0987Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-0987Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-1148Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-1148Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-1148Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-1148Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent