FDA Approves Multiple Labeling Supplements for MirtaZAPINE (ANDA 076901)

The FDA’s Abbreviated New Drug Application (ANDA) 076901 lists MirtaZAPINE as an oral, orally disintegrating tablet available in 15 mg, 30 mg and 45 mg strengths. All three product entries are marked as discontinued. The application’s submission history shows an original (ORIG) submission (number 1) approved on 28 June 2005, followed by numerous supplemental (SUPPL) submissions primarily for labeling updates. Labeling supplements (numbers 3, 5, 6, 7, 11, 13, 16, 17) received approval on dates ranging from 13 November 2007 to 16 July 2025. One manufacturing (CMC) supplemental submission (number 12) was approved on 18 March 2015, though its review priority is listed as UNKNOWN. No active marketing status is indicated for MirtaZAPINE; the products remain discontinued despite the series of approved labeling changes.