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Zolpimist FDA Approval History

FDA Approved: Yes (First approved December 19, 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 Timeline for Zolpimist

Dec 22, 2008ApprovalNovaDel 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 TreatInsomnia Accepted for Filing by the U.S. Food and DrugAdministration

Further information

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