Granules India gets US FDA approval for loperamide hydrochloride and simethicone tablets
Granules India has received the US Food & Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for loperamide hydrochloride and simethicone tablets, 2 mg/125 mg (OTC). It is bioequivalent to the reference listed drug product, imodium multi-symptom relief tablets, 2 mg/125 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Loperamide hydrochloride and simethicone tablets are indicated to relieve symptoms of diarrhoea plus bloating, pressure and cramps, commonly referred to as gas. Granules now have a total of 52 ANDA approvals from US FDA (50 Final approvals and 2 tentative approvals). The imodium multi-symptom relief brand and store brands had combined US sales of approximately $60 million MAT for the most recent twelve months.
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