FDA.reportPublic FDA data

Application 213186

Type
ANDA
Sponsor
GRANULES 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
42291-776RamelteonRamelteonAvKAREANDACurrent
42291-776RamelteonRamelteonAvKAREANDACurrent
63629-8531RamelteonRamelteonBryant Ranch PrepackANDACurrent
63629-8531RamelteonRamelteonBryant Ranch PrepackANDACurrent
63629-8531RamelteonRamelteonBryant Ranch PrepackANDACurrent
70010-028RamelteonRamelteonGranules Pharmaceuticals Inc.ANDACurrent
70010-028RamelteonRamelteonGranules Pharmaceuticals Inc.ANDACurrent
70010-028RamelteonRamelteonGranules Pharmaceuticals Inc.ANDACurrent
70010-028RamelteonRamelteonGranules Pharmaceuticals Inc.ANDACurrent
71205-918RamelteonRamelteonProficient Rx LPANDACurrent
71205-918RamelteonRamelteonProficient Rx LPANDACurrent