These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion's untitled letters. The agency may have redacted or edited some of the letters to remove confidential information.
|Company / Individual||Product / Issue||Issued Date|
|BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous use||7/72021|
|NDA 212728 NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use||3/8/2021|