FDA.reportPublic FDA data

Application 212650

Type
ANDA
Sponsor
I3 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
50436-3980RamelteonRamelteonUnit Dose ServicesANDACurrent
52817-235RamelteonRamelteonTruPharma, LLCANDACurrent
52817-235RamelteonRamelteonTruPharma, LLCANDACurrent
55700-874RamelteonRamelteonQuality Care Products, LLCANDACurrent
55700-874RamelteonRamelteonQuality Care Products, LLCANDACurrent
71335-2186RamelteonRamelteonBryant Ranch PrepackANDACurrent
72189-369RamelteonRamelteonDirect_RxANDACurrent
72319-005RamelteonRamelteoni3 Pharmaceuticals, LLCANDACurrent
72319-005RamelteonRamelteoni3 Pharmaceuticals, LLCANDACurrent
80425-0203RamelteonRamelteonAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent