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Zolpimist Approval History

  • FDA approved: Yes (First approved December 19th, 2008)
  • Brand name: Zolpimist
  • Generic name: zolpidem tartrate
  • 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.

FDA Approval History for Zolpimist

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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