Generic pharmaceuticals company Breckenridge Pharmaceutical Inc announced on Thursday the launch of Zolpidem Tartrate Extended-Release Tablets, USP, manufactured by Centaur Pharmaceuticals Pvt Ltd.
Breckenridge will market the product under its own label and offer 6.25 mg and 12.5 mg strengths in bottles of 100.
Zolpidem Tartrate Extended-Release Tablets, USP are a generic version of Ambien CR, a prescription medicine for adults with trouble falling asleep and/or waking up often during the night.
The US Food and Drug Administration (FDA) previously granted final approval of the product's Abbreviated New Drug Application.
According to industry sales data, Ambien CR and its generics had annual sales of USD42m during the 12 months ending May 2021.
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