FDA Approves Labeling Updates for Generic Levofloxacin Tablets (ANDA 076361)

The Food and Drug Administration (FDA) has granted approval for multiple labeling submissions related to generic levofloxacin tablets submitted under ANDA 076361. The products are oral tablets available in three strengths—250 mg, 500 mg, and 750 mg—and are designated as prescription‑only. Since the original submission (submission 1) was approved on June 20 2011, the sponsor has filed a series of supplemental labeling applications. All listed submissions have received an "AP" (approved) status. Notable approvals include submission 2 (Nov 20 2011), submission 3 (Feb 10 2012), submission 5 (May 24 2012), submission 6 (Oct 22 2012), submission 8 (Sept 19 2014), submission 9 (Sept 19 2014), submission 10 and 12 (both Apr 26 2019), submission 16 (Sept 9 2024), among others. Each supplemental filing was classified under the "Labeling" class code, with most reviewed under standard priority. These approvals ensure that the labeling information for the generic levofloxacin tablets remains current and compliant with FDA requirements, supporting continued market availability of these prescription antibiotics.