FDA Approves Sagent Pharmaceuticals' Ephedrine Sulfate Injection (ANDA214528)

The U.S. Food and Drug Administration (FDA) has granted approval for application ANDA214528, covering an injectable solution of Ephedrine Sulfate. The product, marketed under the brand name Ephedrine Sulfate, is administered intravenously at a strength of 50 mg/mL. The drug is manufactured by Sagent Pharmaceuticals (Sagent Pharms Inc.) and is listed under NDC 25021-836-01. The approval follows the original submission (submission number 1) with a standard review priority, and the submission status was recorded as approved on March 9, 2023. This approval adds a prescription‑only, human drug to the market, expanding treatment options that require rapid vasoconstrictive action via the intravenous route.