Nucynta Approval History

  • FDA approved: Yes (First approved November 20th, 2008)
  • Brand name: Nucynta
  • Generic name: tapentadol
  • Company: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
  • Treatment for: Pain

Nucynta (tapentadol) is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.

FDA Approval History for Nucynta

DateArticle
Aug 29, 2012Approval FDA Approves Nucynta ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Aug 26, 2011Approval Nucynta ER (Tapentadol Extended-Release Tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain
Nov 21, 2008Approval FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
Jan 24, 2008New Drug Application Submitted to FDA for Investigational Analgesic Tapentadol Immediate Release Tablets

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