"The company has received ANDA approval for Motelukast Sodium tablets from the United States Food and Drug Administration (USFDA)," Unichem Laboratories said in a filing to BSE.
The product will be commercialised from the company's Goa plant, it added.
The product is generic version of Merck Sharp & Dohme Corp's Singulair tablets in the strength of 10 mg, Unichem said.
Montelukast is used for prevention and chronic treatment of asthma, prevention of exercise induced bronchoconstriction and allergic rhinitis, it added.
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