Last Updated on October 10, 2024 by The Health Master
New Delhi: Unichem Laboratories Ltd said it has received approval from the US health regulator to market its generic version of labetalol hydrochloride tablets used to treat high blood pressure.
The approval granted by the US Food and Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of labetalol hydrochloride tablets of strengths 100 mg, 200 mg, and 300 mg, the company said in a regulatory filing.
These are generic equivalent of Normodyne tablets of 100 mg, 200 mg and 400 mg of Schering Corp.
The tablets will be produced at the company’s Goa plant, Unichem said.
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