Application 203918

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM PHENYLBUTYRATESODIUM PHENYLBUTYRATEPOWDER;ORAL3GM/TEASPOONFULNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-006Sodium PhenylbutyrateSodium PhenylbutyratePar Pharmaceutical, Inc.ANDACurrent
49884-006Sodium PhenylbutyrateSodium PhenylbutyratePar Pharmaceutical, Inc.ANDACurrent