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Dyloject Approval History

  • FDA approved: Yes (First approved December 23rd, 2014)
  • Brand name: Dyloject
  • Generic name: diclofenac sodium
  • Dosage form: Injection
  • Company: Javelin Pharmaceuticals, Inc.
  • Treatment for: Pain

Dyloject (diclofenac sodium injection) is an intravenous non-steroidal anti-inflammatory drug (NSAID) for the management of acute moderate-to-severe pain in adults.

Development History and FDA Approval Process for Dyloject

Dec 30, 2014Approval Hospira Receives U.S. FDA Approval of Proprietary Analgesic Dyloject (diclofenac sodium) Injection
Feb 17, 2010Javelin Pharmaceuticals' Receives FDA PDUFA Date for Dyloject NDA
Feb  2, 2010FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal Review
Dec  2, 2009Javelin Pharmaceuticals Submits Dyloject New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults

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