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Unichem Lab gets USFDA nod for Montelukast Chewable tablets

Unichem Laboratories has received final ANDA approval from the United States Food and Drug Administration (USFDA), to market in the US, its Montelukast Chewable tablets, 4 mg and 5 mg.

The Montelukast chewable tablets are the AB rated generic equivalent of Merck Sharp & Dohme Corporation’s Singulair tablets, 4 mg and 5 mg. The product will be commercialized from Unichem’s goa plant.

Further, it is suggested for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, and the prevention of exercise-induced broncho constriction in patients 15 years of age and older, and also used for the relief of symptoms of allergic rhinitis.

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