Granules receives USFDA approval for Loperamide Hydrochloride and Simethicone Tablets

3 Sep 2022 , 01:34 AM

Granules India announced today that the US Food Drug Administration US FDA has approved its Abbreviated New Drug Application ANDA for Loperamide Hydrochloride and Simethicone Tablets 2 mg125 mg OTC It is bioequivalent to the reference listed drug product Imodium Multi-Symptom Relief Tablets 2 mg125 mg of Johnson Johnson Consumer Inc McNeil Consumer Healthcare Division Loperamide Hydrochloride and Simethicone Tablets are indicated to relieve symptoms of diarrhea 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 65039; brand and store brands had combined US sales of approximately $60million MAT for the most recent twelve months