FDA Approves Minocycline Hydrochloride Tablets (ANDA 065131)

The U.S. Food and Drug Administration has approved an abbreviated new drug application (ANDA) numbered 065131 for minocycline hydrochloride tablets. The product, marketed under the brand name MINOCYCLINE HYDROCHLORIDE, is manufactured by Strides Pharma Science Limited (sponsor STRIDES PHARMA INTL) and is intended for oral administration. Three tablet strengths are listed: 50 mg, 75 mg, and 100 mg base equivalents. All three strengths are classified as prescription human drugs. The FDA labeling submissions linked to this ANDA were approved on several dates, including the original application on 16 April 2003 and subsequent labeling updates on 5 January 2004, 30 June 2008, 19 January 2010, 11 May 2012, and 4 March 2014. The approval includes package NDC codes 64380‑154‑01, 64380‑155‑01, and 64380‑156‑01.