FDA Grants ANDA216294 Approval for Calcitonin Salmon Injection by Amneal

The U.S. Food and Drug Administration has approved the abbreviated new drug application (ANDA) number 216294 for a calcitonin salmon injectable product. The product, marketed under the brand name Calcitonin Salmon, contains the active ingredient calcitonin salmon at a strength of 200 IU/mL and is supplied as an injectable dosage form for intramuscular or subcutaneous administration. It is listed under NDC 70121-1650-2 and is classified as a human prescription drug. The application was submitted by Amneal Pharmaceuticals LLC, and the FDA’s submission status is listed as “AP” with a standard review priority. The submission status date is September 26, 2025.