Hyderabad, Aug 30: Granules India Limited on Tuesday announced that the US Food & Drug Administration (US FDA) has approved 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, Granules Company said in a release here. Loperamide Hydrochloride and Simethicone Tablets are indicated to relieve symptoms of […]
Uniindia: Mumbai, Aug 30 (UNI) Pharma major Granules India on Tuesday said the US Food and Drug Administration (USFDA) has approved its Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC).
Johnson & Johnson McNeil barred from manufacturing drugs at Fort Washington plant until FDA determines operations are in compliance with a consent decree - PMLiVE