FDA.reportPublic FDA data

Application 204179

Type
ANDA
Sponsor
AMNEAL PHARMS

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
50436-0724Rabeprazole SodiumRabeprazoleUnit Dose ServicesANDACurrent
65162-724Rabeprazole SodiumRabeprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-724Rabeprazole SodiumRabeprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-724Rabeprazole SodiumRabeprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-724Rabeprazole SodiumRabeprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-724Rabeprazole SodiumRabeprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-724Rabeprazole SodiumRabeprazoleAmneal Pharmaceuticals LLCANDACurrent
68788-8997Rabeprazole SodiumRabeprazolePreferred Pharmaceuticals Inc.ANDACurrent