FDA Approves Chartwell Molecular Lamotrigine Tablet ANDA077783

The U.S. Food and Drug Administration has granted approval for ANDA 077783, submitted by Chartwell Molecular, covering oral lamotrigine tablets. The approved application includes four tablet strengths—25 mg, 100 mg, 150 mg, and 200 mg—each listed with a product number (001‑004). All four products are currently marked as discontinued in the FDA database. The approval was accompanied by a series of labeling submissions (numbers 3, 6, 7, 9, 13, 14) that received standard review and were approved on dates ranging from September 20 2016 to October 23 2018. An original submission (number 1) was also approved on November 1 2010. No reference drug or reference standard was identified for these products.