Treats acute symptomatic hypocalcemia. ANDA 217463, held by Square Pharms PLC. Calcium Chloride.
As of Nov 15, 2026, ANDA 217463 (Calcium Chloride 10%), held by Square Pharms PLC, was first approved by FDA on Sep 29, 2025, with 0 approved supplements and 0 published complete response letters.
Calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use The safety and effectiveness of calcium chloride injection for long-term use has not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcium Chloride 10%100MG/ML · injectable;injection | Calcium Chloride | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
