FDA Approves Dexamethasone Sodium Phosphate Injection (ANDA 084282)

The U.S. Food and Drug Administration has granted approval for Abbreviated New Drug Application (ANDA) 084282 covering DEXAMETHASONE SODIUM PHOSPHATE injection. The product is listed under the brand name DEXAMETHASONE SODIUM PHOSPHATE, classified as a human prescription drug and available in injectable dosage form for routes such as intra‑articular, intralesional, intramuscular, intravenous and soft‑tissue administration. The approved injectable is manufactured by Hikma Pharmaceuticals USA Inc. and Civica, Inc. and is identified by several package NDC codes, including 0641‑0367‑21, 0641‑0367‑25, 0641‑6145‑01, 0641‑6145‑25, 0641‑6146‑01, 0641‑6146‑10, 0641‑6146‑25, 72572‑120‑01, 72572‑120‑25, 72572‑122‑01 and 72572‑122‑25. The submission history shows an original approval on 1975‑07‑15 (submission 1) and multiple supplemental submissions for manufacturing (CMC) and labeling between 1988 and 1999, the latest being submission 43 on 1999‑09‑07.