ANDA 77394, held by Hospira. Sodium Bicarbonate.
As of Nov 15, 2026, ANDA 77394 (Sodium Bicarbonate), held by Hospira, was first approved by FDA on Nov 9, 2005, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2005 | Original application | Approved |
| Sodium Bicarbonate44.6MEQ/50ML (0.9MEQ/ML) · solution;intravenous | Sodium Bicarbonate | Discontinued |
| Sodium Bicarbonate50MEQ/50ML (1MEQ/ML) · solution;intravenous | Sodium Bicarbonate | Discontinued |
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
