FDA.reportPublic FDA data

Application 209735

Type
ANDA
Sponsor
SUN PHARM

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
50090-5365Esomeprazole magnesiumEsomeprazole magnesiumA-S Medication SolutionsANDACurrent
50090-5365Esomeprazole magnesiumEsomeprazole magnesiumA-S Medication SolutionsANDACurrent
50090-5552Esomeprazole magnesiumEsomeprazole magnesiumA-S Medication SolutionsANDACurrent
63304-734Esomeprazole magnesiumEsomeprazole magnesiumSun Pharmaceutical Industries, IncANDACurrent
63304-734Esomeprazole magnesiumEsomeprazole magnesiumSun Pharmaceutical Industries, IncANDACurrent
63304-734Esomeprazole magnesiumEsomeprazole magnesiumSun Pharmaceutical Industries, IncANDACurrent
63304-734Esomeprazole magnesiumEsomeprazole magnesiumSun Pharmaceutical Industries, IncANDACurrent
63304-735Esomeprazole magnesiumEsomeprazole magnesiumSun Pharmaceutical Industries, IncANDACurrent
63304-735Esomeprazole magnesiumEsomeprazole magnesiumSun Pharmaceutical Industries, IncANDACurrent
63304-735Esomeprazole magnesiumEsomeprazole magnesiumSun Pharmaceutical Industries, IncANDACurrent
63304-735Esomeprazole magnesiumEsomeprazole magnesiumSun Pharmaceutical Industries, IncANDACurrent
68071-2241Esomeprazole magnesiumEsomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2241Esomeprazole magnesiumEsomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5270Esomeprazole magnesiumEsomeprazole magnesiumNuCare Pharmaceuticals,Inc.ANDACurrent
71335-2011Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71335-2011Esomeprazole magnesiumEsomeprazole magnesiumBryant Ranch PrepackANDACurrent
71610-665Esomeprazole magnesiumEsomeprazole magnesiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0183Esomeprazole MagnesiumEsomeprazole MagnesiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0183Esomeprazole MagnesiumEsomeprazole MagnesiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0183Esomeprazole MagnesiumEsomeprazole MagnesiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent