FDA.reportPublic FDA data

Application 205429

Type
ANDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPSONEDAPSONETABLET;ORAL25MGNoNo
002DAPSONEDAPSONETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-333DapsonedapsoneAlvogen Inc.ANDACurrent
47781-333DapsonedapsoneAlvogen Inc.ANDACurrent
47781-333DapsonedapsoneAlvogen Inc.ANDACurrent
47781-334DapsonedapsoneAlvogen Inc.ANDACurrent
47781-334DapsonedapsoneAlvogen Inc.ANDACurrent
47781-334DapsonedapsoneAlvogen Inc.ANDACurrent