FDA Approves PROCHLORPERAZINE EDISYLATE Injection (ANDA212257)

The U.S. Food and Drug Administration has granted approval for the Abbreviated New Drug Application (ANDA) number 212257 for PROCHLORPERAZINE EDISYLATE. The product, marketed by Somerset Therapeutics, LLC, is an injectable formulation available for intramuscular and intravenous administration. The original submission received an approved status on September 13, 2024, and a labeling supplement was approved on June 1, 2026. The drug is classified as a prescription human medication, with the generic and brand names both listed as PROCHLORPERAZINE EDISYLATE. It is supplied under NDC codes 70069-371-01 and 70069-371-25.