FDA.reportPublic FDA data

Application 216349

Type
ANDA
Sponsor
GRAVITI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-880ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMRising Pharma Holdings, Inc.ANDACurrent
69844-050esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent
69844-050esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent