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Zolpimist Approval History

  • FDA approved: Yes (First approved December 19th, 2008)
  • Brand name: Zolpimist
  • Generic name: zolpidem tartrate
  • Dosage form: Oral Spray
  • Company: NovaDel Pharma, Inc.
  • Treatment for: Insomnia

Zolpimist is an oral spray formulation of zolpidem, the drug contained in Ambien. Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Development History and FDA Approval Process for Zolpimist

Dec 22, 2008Approval NovaDel Pharma Receives FDA Approval of Zolpimist
Sep 19, 2008NovaDel Pharma Announces PDUFA Deadline Extension on Zolpimist
Jan 23, 2008NovaDel's New Drug Application for ZolpiMist Oral Spray to Treat Insomnia Accepted for Filing by the U.S. Food and Drug Administration

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