FDA.reportPublic FDA data

Application 211333

Type
ANDA
Sponsor
VISTAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FELBAMATEFELBAMATESUSPENSION;ORAL600MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66689-825FelbamateFelbamateVistaPharm, Inc.ANDACurrent
66689-825FelbamateFelbamateVistaPharm, Inc.ANDACurrent
66689-825FelbamateFelbamateVistaPharm, Inc.ANDACurrent
66689-825FelbamateFelbamateVistaPharm, Inc.ANDACurrent
66689-825FelbamateFelbamateVistaPharm, Inc.ANDACurrent
66689-825FelbamateFelbamateVistaPharm, Inc.ANDACurrent
70954-051FelbamateFelbamateNovitium Pharma LLCANDACurrent