The Food and Drug Administration (FDA, Agency, or we) has determined that OZOBAX (baclofen) oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. FDA-2026-P-6298), under 21 CFR 10.30, requesting that the Agency determine whether OZOBAX (baclofen) oral solution, 5 mg/5 mL, was ( printed page 51493) withdrawn from sale for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting OZOBAX (baclofen) oral solution, 5 mg/5 mL was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of OZOBAX (baclofen) oral solution, 5 mg/5 mL, from sale.