ANDA 219037, held by Milla Pharms. Calcium Gluconate.
As of Nov 15, 2026, ANDA 219037 (Calcium Gluconate In Sodium Chloride), held by Milla Pharms, was first approved by FDA on Aug 28, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2026 | 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 |
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
