Treats acute symptomatic hypocalcemia. ANDA 216611, held by Amneal. Calcium Gluconate.
As of Nov 15, 2026, ANDA 216611 (Calcium Gluconate), held by Amneal, was first approved by FDA on May 10, 2024, 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 10, 2024 | 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
