FDA Grants Labeling Approval for Olmesartan Medoxomil Tablets (ANDA 078276)

The U.S. Food and Drug Administration (FDA) issued an approval for labeling of oral Olmesartan Medoxomil tablets under ANDA 078276. The application was submitted by Rising. The ANDA covers three tablet strengths—5 mg, 20 mg, and 40 mg—each listed as discontinued in the FDA database. The dosage form is oral tablet. The original submission (ORIG) received an approval letter dated October 26 2016, with the accompanying letter dated October 31 2016. Subsequent labeling supplements (SUPPL) were approved on September 12 2025. No reference drug status was indicated, and the products are not designated as reference standards.