Federal Register Notice: FDA is correcting a 3/4 Federal Register notice that announced the withdrawal of approval of 76 NDAs and 60 ANDAs. The document inadvertently withdrew approval of an ANDA for Sotalol Hydrochloride tablets, 80 mg, 120 mg, and 160 mg, held by TorPharm, c/o Apotex Corp. FDA confirms that approval of ANDA 76-214 is still in effect. To view this notice, click here.
