FDA.reportPublic FDA data

Application 078936

Type
ANDA
Sponsor
MYLAN

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
0378-2350Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Pharmaceuticals Inc.ANDACurrent
0378-2350Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Pharmaceuticals Inc.ANDACurrent
0378-2351Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Pharmaceuticals Inc.ANDACurrent
0378-2351Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Pharmaceuticals Inc.ANDACurrent
0615-8299Esomeprazole MagnesiumEsomeprazole MagnesiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8299Esomeprazole MagnesiumEsomeprazole MagnesiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42292-009Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Institutional Inc.ANDACurrent
42292-009Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Institutional Inc.ANDACurrent
42292-009Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Institutional Inc.ANDACurrent
42292-010Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Institutional Inc.ANDACurrent
42292-010Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Institutional Inc.ANDACurrent
42292-010Esomeprazole MagnesiumEsomeprazole MagnesiumMylan Institutional Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9200ORIG2015-08-06
18489ORIG2015-08-04
9201ORIG2015-02-06