FDA.reportPublic FDA data

Application 204395

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM PHENYLBUTYRATESODIUM PHENYLBUTYRATETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-170Sodium PhenylbutyrateSodium Phenylbutyrate Tablets, 500 mgPar Pharmaceutical, Inc.ANDACurrent
49884-170Sodium PhenylbutyrateSodium Phenylbutyrate Tablets, 500 mgPar Pharmaceutical, Inc.ANDACurrent