Treats acute symptomatic hypocalcemia. ANDA 217174, held by Amneal. Calcium Gluconate.
As of Nov 15, 2026, ANDA 217174 (Calcium Gluconate In Sodium Chloride), held by Amneal, was first approved by FDA on Sep 5, 2023, with 1 approved supplement and 0 published complete response letters.
Calcium gluconate in sodium chloride 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 |
|---|---|---|---|
| Sep 5, 2023 | Original application | Approved |
| Calcium Gluconate In Sodium Chloride1GM/50ML (20MG/ML) · solution;intravenous | Calcium Gluconate | Rx |
| Calcium Gluconate In Sodium Chloride2GM/100ML (20MG/ML) · solution;intravenous | Calcium Gluconate | Rx |
| Jun 9, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 5, 2023 | Original application | Approved |
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
