FDA.reportPublic FDA data

Application 204237

Type
ANDA
Sponsor
RUBICON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3430Rabeprazole SodiumRABEPRAZOLE SODIUMA-S Medication SolutionsANDACurrent
51991-683Rabeprazole SodiumRABEPRAZOLE SODIUMBreckenridge Pharmaceutical, Inc.ANDACurrent
60760-972RABEPRAZOLE SODIUMrabeprazole sodiumSt. Mary's Medical Park PharmacyANDACurrent
63187-945Rabeprazole SodiumRABEPRAZOLE SODIUMProficient Rx LPANDACurrent
68071-4353Rabeprazole SodiumRABEPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7143Rabeprazole SodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7143Rabeprazole SodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
70518-3209RABEPRAZOLE SODIUMrabeprazole sodiumREMEDYREPACK INC.ANDACurrent
70518-3209RABEPRAZOLE SODIUMrabeprazole sodiumREMEDYREPACK INC.ANDACurrent
70518-3209RABEPRAZOLE SODIUMrabeprazole sodiumREMEDYREPACK INC.ANDACurrent
71205-603RABEPRAZOLE SODIUMrabeprazole sodiumProficient Rx LPANDACurrent
71205-603RABEPRAZOLE SODIUMrabeprazole sodiumProficient Rx LPANDACurrent
71335-0636Rabeprazole SodiumRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent
72888-059RABEPRAZOLE SODIUMrabeprazole sodiumAdvagen Pharma LimitedANDACurrent
72888-059RABEPRAZOLE SODIUMrabeprazole sodiumAdvagen Pharma LimitedANDACurrent
76420-223RABEPRAZOLE SODIUMrabeprazole sodiumAsclemed USA, Inc.ANDACurrent