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Home » FDA Grants Tentative Approval to Teva's Generic Ambien
FDA Grants Tentative Approval to Teva's Generic Ambien
June 1, 2005
Teva Pharmaceutical has received FDA approval for its zolpidem tartrate tablets in 5-mg and 10-mg doses.
The tablets are the generic version of sanofi-synthelabo's Ambien tablets, which are indicated for the short-term treatment of insomnia. Teva expects final approval of the tablets when sanofi-synthelabo's patent covering Ambien tablets expires in October 2006.
KEYWORDS Drug Pipeline Alert
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