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  6. Untitled Letters 2020
  1. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Untitled Letters 2020

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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