FDA Approves Hikma Phenytoin Sodium Injection (ANDA 084307)

The U.S. Food and Drug Administration (FDA) has granted approval for Abbreviated New Drug Application (ANDA) 084307 submitted by Hikma Pharmaceuticals USA Inc. The approved product is marketed under the brand name PHENYTOIN SODIUM and contains the generic active ingredient phenytoin sodium. The injectable is classified as a human prescription drug and is supplied in an injectable dosage form at a strength of 50 mg/mL. It is authorized for both intramuscular and intravenous routes of administration. The approval encompasses a range of package National Drug Codes (NDCs), including 0641-0493-21, 0641-0493-25, 0641-2555-41, 0641-2555-10, 0641-2555-45, 0641-6138-01, 0641-6138-25, 0641-6139-01, 0641-6139-10, and 0641-6139-25, corresponding to product NDCs 0641-0493, 0641-2555, 0641-6138, and 0641-6139. The submission record shows a series of labeling and manufacturing (CMC) supplements that were approved between 1987 and 1998, reflecting the product’s regulatory history. The product is listed as a reference drug and is intended for prescription use only.