Home » CARACO ANNOUNCES TENTATIVE APPROVAL FOR ZOLPIDEM TARTRATE
CARACO ANNOUNCES TENTATIVE APPROVAL FOR ZOLPIDEM TARTRATE
The FDA has granted tentative approval to Caraco Pharmaceutical Laboratories for an abbreviated new drug application for Zolpidem Tartrate in 5- and 10-mg dosage strengths.
Final approval of this product is anticipated subsequent to the expiry of patent protection in October 2006. Caraco's Zolpidem Tartrate is the generic equivalent of sanofi-aventis' short- term insomnia treatment Ambien.
KEYWORDS Drug Pipeline Alert
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