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Nucynta Approval History

  • FDA approved: Yes (First approved November 20th, 2008)
  • Brand name: Nucynta
  • Generic name: tapentadol
  • Dosage form: Tablets
  • 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.

Development History and FDA Approval Process for Nucynta

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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