FDA Approves ANDA 076392 for Mefloquine Hydrochloride

The U.S. Food and Drug Administration has granted approval for Abbreviated New Drug Application (ANDA) 076392 covering Mefloquine Hydrochloride, a prescription oral tablet. The product is marketed under the brand and generic name Mefloquine Hydrochloride and is manufactured by Teva Pharmaceuticals USA, Inc. It is available as 250 mg tablets (product number 001) with NDC codes 0555-0171-88 and 0555-0171-78. The sponsor listed for the application is BARR. The approval follows a series of labeling submissions (submission numbers 1, 3, 4, 5, 8, and 9) with the most recent labeling submissions dated July 26, 2013 and October 11, 2016. All submissions were approved (status "AP"). The drug is classified as a human prescription drug, administered orally, and is not designated as a reference drug. The FDA review priority was standard.