FDA.reportPublic FDA data

Application 208644

Type
ANDA
Sponsor
ALKEM LABS LTD

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
45865-123Rabeprazole SodiumRabeprazole SodiumMedsource PharmaceuticalsANDACurrent
50090-4751Rabeprazole SodiumRabeprazole SodiumA-S Medication SolutionsANDACurrent
50090-4751Rabeprazole SodiumRabeprazole SodiumA-S Medication SolutionsANDACurrent
55700-767Rabeprazole SodiumRabeprazole SodiumQuality Care Products, LLCANDACurrent
55700-767Rabeprazole SodiumRabeprazole SodiumQuality Care Products, LLCANDACurrent
55700-767Rabeprazole SodiumRabeprazole SodiumQuality Care Products, LLCANDACurrent
60760-560Rabeprazole SodiumRabeprazole SodiumSt. Mary's Medical Park PharmacyANDACurrent
60760-560Rabeprazole SodiumRabeprazole SodiumSt. Mary's Medical Park PharmacyANDACurrent
67877-443Rabeprazole SodiumRabeprazole SodiumAscend Laboratories, LLCANDACurrent
67877-443Rabeprazole SodiumRabeprazole SodiumAscend Laboratories, LLCANDACurrent
67877-443Rabeprazole SodiumRabeprazole SodiumAscend Laboratories, LLCANDACurrent
67877-443Rabeprazole SodiumRabeprazole SodiumAscend Laboratories, LLCANDACurrent
68788-7459Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7459Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7459Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7459Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70518-2590Rabeprazole SodiumRabeprazole SodiumREMEDYREPACK INC.ANDACurrent
70934-403Rabeprazole SodiumRabeprazole SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-403Rabeprazole SodiumRabeprazole SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-292Rabeprazole SodiumRabeprazole SodiumProficient Rx LPANDACurrent
71205-292Rabeprazole SodiumRabeprazole SodiumProficient Rx LPANDACurrent
71205-292Rabeprazole SodiumRabeprazole SodiumProficient Rx LPANDACurrent
71205-292Rabeprazole SodiumRabeprazole SodiumProficient Rx LPANDACurrent
71335-1100Rabeprazole SodiumRabeprazole SodiumBryant Ranch PrepackANDACurrent
71335-1100Rabeprazole SodiumRabeprazole SodiumBryant Ranch PrepackANDACurrent
71335-1100Rabeprazole SodiumRabeprazole SodiumBryant Ranch PrepackANDACurrent
71335-1100Rabeprazole SodiumRabeprazole SodiumBryant Ranch PrepackANDACurrent
72189-169RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXANDACurrent
72189-169RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXANDACurrent
72189-169RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXANDACurrent
72189-169RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXANDACurrent
80425-0094AciphexRabeprazole Sodium 20mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0094Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0094Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0094Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0134AciphexRabeprazole 20mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0134Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0134Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0134Rabeprazole SodiumRabeprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent