ANDA 217891, held by Cipla. Calcium Gluconate.
As of Nov 15, 2026, ANDA 217891 (Calcium Gluconate In Sodium Chloride), held by Cipla, was first approved by FDA on Sep 17, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2026 | Original application | Approved | None posted |
| 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 |
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
