CDER New August 29, 2018

August 28, 2018

• Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trial Snapshots:
  • DIACOMIT
  • OXERVATE
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Dexrazoxane Injection (Updated - Currently in Shortage)
  • Olaparib (LYNPARZA®) Capsules (New - Discontinuation)
  •  Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)