FDA Grants ANDA077797 Approval for Cycbenzaprine Hydrochloride Tablets

The U.S. Food and Drug Administration (FDA) has approved Abbreviated New Drug Application (ANDA) number ANDA077797 for Cycbenzaprine Hydrochloride tablets. The product is an oral prescription drug marketed under the brand name Cycbenzaprine Hydrochloride, manufactured by Solco Healthcare U.S., LLC, with Prinston Inc. listed as the sponsor. Two dosage strengths are authorized: 5 mg tablets (product number 001) and 10 mg tablets (product number 002). Both are labeled as prescription‑only. The approval follows a series of labeling submissions, including the original filing on 28 Feb 2007 and subsequent labeling amendments on 6 Jan 2009, 7 Aug 2008, and 11 Mar 2013.