FDA gives the go-ahead for generic Ambien
The sedative-hypnotic is indicated for the short-term treatment of insomnia. Zolpidem tablets in formulations of 5 and 10 mg are manufactured by multiple U.S. generic drug companies.
The FDA approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. The sedative-hypnotic is indicated for the short-term treatment of insomnia. Zolpidem tablets in formulations of 5 and 10 mg are manufactured by multiple U.S. generic drug companies. Thirteen manufacturers have received FDA approval for manufacturing zolpidem tablets. They are: Mylan, Teva, Roxane, Watson, Ranbaxy, Dr. Reddy's Laboratories, Apotex, Synthon Pharmaceuticals, Genpharm, Mutual Pharmaceutical, Caraco, Carlsbad Technology, and Lek Pharmaceuticals.
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