FDA Approves Leading Pharma’s Lorazepam Tablet ANDA078203

The U.S. Food and Drug Administration (FDA) issued an approval for application ANDA078203 on July 30, 2007. The approval covers generic Lorazepam tablets produced by Leading Pharma, LLC and marketed as a prescription drug. Three tablet strengths are authorized: 0.5 mg, 1 mg, and 2 mg. All products are administered orally and are identified by multiple NDC codes, including 69315‑904‑01, 69315‑904‑05, 69315‑904‑10, 69315‑905‑01, 69315‑905‑05, 69315‑905‑10, 69315‑906‑01, 69315‑906‑05, and 69315‑906‑10. The submission was an original (ORIG) filing, assigned submission number 1, and received an “AP” (approved) status. The product is classified under the benzodiazepine class and listed as a human prescription drug. This approval adds a new generic option for Lorazepam, a benzodiazepine indicated for anxiety and related disorders, to the U.S. market.