Treats acute symptomatic hypocalcemia. ANDA 217524, held by Amneal. Calcium Chloride.
As of Nov 15, 2026, ANDA 217524 (Calcium Chloride 10%), held by Amneal, was first approved by FDA on Jul 8, 2024, with 1 approved supplement 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 |
|---|---|---|---|
| Jul 8, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcium Chloride 10%100MG/ML · injectable;injection | Calcium Chloride | Rx |
| Oct 21, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 8, 2024 | Original application | Approved | None posted |
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
