Treats acute symptomatic hypocalcemia. ANDA 218133, held by Somerset. Calcium Chloride.
As of Nov 15, 2026, ANDA 218133 (Calcium Chloride 10%), held by Somerset, was first approved by FDA on Dec 17, 2024, 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 |
|---|---|---|---|
| Dec 17, 2024 | 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
