FDA.reportPublic FDA data

Application 211567

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAMELTEONRAMELTEONTABLET;ORAL8MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1344RamelteonRamelteonZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1344RamelteonRamelteonZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1344RamelteonRamelteonZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1495RamelteonRamelteonCadila Healthcare LimitedANDACurrent
70771-1495RamelteonRamelteonZydus Lifesciences LimitedANDACurrent
70771-1495RamelteonRamelteonCadila Healthcare LimitedANDACurrent
71335-1853RamelteonRamelteonBryant Ranch PrepackANDACurrent
72189-153RAMELTEONRAMELTEONDIRECT RXANDACurrent