Treats acute symptomatic hypocalcemia. ANDA 218840, held by Caplin. Calcium Gluconate.
As of Nov 15, 2026, ANDA 218840 (Calcium Gluconate), held by Caplin, was first approved by FDA on May 4, 2026, with 0 approved supplements and 0 published complete response letters.
Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2026 | Original application | Approved | None posted |
| Calcium Gluconate1GM/10ML (100MG/ML) · solution;intravenous | Calcium Gluconate | Rx |
| Calcium Gluconate5GM/50ML (100MG/ML) · solution;intravenous | Calcium Gluconate | Rx |
| Calcium Gluconate10GM/100ML (100MG/ML) · solution;intravenous | Calcium Gluconate | 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
