FDA Orange Book — New Patent Listings

N022503 Metaxalone 640mg Tablet, Primus Pharmaceuticals

FDA Orange Book listing for NDA 022503 for Metaxalone 640mg oral tablet, approved June 1, 2015, held by Primus Pharmaceuticals Inc. The product is designated as both Reference Listed Drug and Reference Standard, indicating it serves as the comparator product for generic drug approval applications. Marketing status is Prescription only.

Sotalol Hydrochloride 150mg/10ml NDA 022306

Altathera Pharmaceuticals LLC received FDA approval for Sotalol Hydrochloride (150mg/10ml, 15mg/ml) solution for intravenous administration under NDA 022306, approved July 2, 2009. The product is listed as both a Reference Listed Drug and Reference Standard with Prescription marketing status. Patent and exclusivity information is available through the linked Orange Book patent info page.

Nexterone Amiodarone Hydrochloride Injectable Patent Details

FDA Orange Book listing for Nexterone (Amiodarone Hydrochloride) injectable drug products under NDA 022325, held by Baxter Healthcare Corp. Three product formulations are listed: 150MG/100ML (1.5MG/ML) and 360MG/200ML (1.8MG/ML), both approved November 16, 2010 with Prescription marketing status; and 50MG/ML approved December 24, 2008 with Discontinued marketing status. All formulations are identified as Reference Listed Drugs. Patent and exclusivity information is available via linked pages for each product number.