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Edluar FDA Approval History

FDA Approved: Yes (First approved March 13, 2009)
Brand name: Edluar
Generic name: zolpidem
Dosage form: Sublingual Tablets
Previous Name: Sublinox
Company: Orexo and Meda AB
Treatment for: Insomnia

Edluar (formerly Sublinox) is a fast-acting sublingual tablet formulation of the widely used drug zolpidem. Edluar is approved for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Development timeline for Edluar

Mar 16, 2009Approval Orexo's Edluar (formerly Sublinox) receives FDA approval for the treatment of insomnia
Jul 29, 2008Meda: The FDA has accepted for filing the registration application for Sublinox
May 15, 2008Orexo Has Submitted the Registration Application for Sublinox (OX22) to the FDA

Further information

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