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  6. Untitled Letters 2022
  1. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Untitled Letters 2022

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 Issued Date
     

Eli Lilly & Company

BLA 125469 TRULICITY® (dulaglutide) injection, for subcutaneous use

01/19/2022

Bausch Health Companies Inc 

NDA 209354 DUOBRII (halobetasol propionate and tazarotene) lotion, for topical use 3/31/2022

Althera Pharmaceuticals

NDA 213072 ROSZET (rosuvastatin ezetimibe) tables, for oral use 6/2/2022

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