FDA Approves ANDA080445 for Meperidine Hydrochloride Injectable Products

The U.S. Food and Drug Administration has approved Abbreviated New Drug Application (ANDA) number 080445 for meperidine hydrochloride injectable products. The approval applies to formulations produced by Hikma Pharmaceuticals USA Inc. The approved products are injectable solutions intended for intramuscular, intravenous, and subcutaneous administration. Four strengths are listed: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. All are classified as prescription‑only human drugs. Submission history shows an original filing on 22 January 1975, followed by multiple labeling supplements (28 December 1988, 20 July 1989, 18 December 1990) and manufacturing (CMC) supplements (30 June 1994, 22 September 1995). All listed submissions have an “AP” (approved) status.