FDA Approves ANDA077652 for Levofloxacin Oral Tablets

The U.S. Food and Drug Administration (FDA) has granted approval for Abbreviated New Drug Application (ANDA) 077652 covering levofloxacin oral tablets. The approval applies to prescription‑only tablets containing the fluoroquinolone antibiotic levofloxacin. Three dosage strengths are authorized: 250 mg (product number 001), 500 mg (product number 002), and 750 mg (product number 003). All products are administered orally and are listed as human prescription drugs. The manufacturers listed on the approval are Zydus Lifesciences Limited and Viona Pharmaceuticals Inc. The submission record shows an original submission (ORIG) on 7 September 2012, followed by labeling supplements (submission numbers 3, 15, and 17) approved in 2014, 2019, and 2020, respectively. A manufacturing (CMC) supplement (submission number 19) received approval on 4 April 2022. All listed submissions have an approved status (AP).