FDA.reportPublic FDA data

Application 210559

Type
ANDA
Sponsor
INDCHEMIE HEALTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
0010ESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALNoNo
002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5777Esomeprazole magnesiumEsomeprazole magnesium delayed release capsulesA-S Medication SolutionsANDACurrent
67877-571Esomeprazole magnesiumEsomeprazole magnesium delayed release capsulesAscend Laboratories, LLCANDACurrent
67877-571Esomeprazole magnesiumEsomeprazole magnesium delayed release capsulesAscend Laboratories, LLCANDACurrent
67877-572Esomeprazole magnesiumEsomeprazole magnesium delayed release capsulesAscend Laboratories, LLCANDACurrent
67877-572Esomeprazole magnesiumEsomeprazole magnesium delayed release capsulesAscend Laboratories, LLCANDACurrent
71205-706Esomeprazole magnesiumEsomeprazole magnesium delayed release capsulesProficient Rx LPANDACurrent
76420-226Esomeprazole magnesiumEsomeprazole magnesium delayed release capsulesAsclemed USA, Inc.ANDACurrent
76420-227Esomeprazole magnesiumEsomeprazole magnesium delayed release capsulesAsclemed USA, Inc.ANDACurrent