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Granules India has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for loperamide hydrochloride and simethicone tablets.
The approved product is the bioequivalent of the reference listed drug Imodium multi-symptom relief tablets of Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Division.
The Imodium multi-symptom relief brand and store brands had combined US sales of approximately $60 million for the most recent 12 months.
Loperamide hydrochloride and simethicone tablets are indicated to relieve symptoms of diarrhoea plus bloating, pressure and cramps, commonly referred to as gas.
Hyderabad-based Granules now has 52 ANDA approvals from the USFDA, according to a release.
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