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.
Office of Prescription Drug Promotion
Company/Individual
Product/Issue
Issue Date
Azurity Pharmaceuticals Inc.
NDA 208400 XATMEP® (methotrexate) oral solution
11/24/2020
Xeris Pharmaceuticals, Inc.
NDA 212097 GVOKETM (glucagon) injection, for subcutaneous use
8/14/2020
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