ANDA 220788, held by Aspiro. Sodium Bicarbonate.
As of Nov 15, 2026, ANDA 220788 (Sodium Bicarbonate), held by Aspiro, was first approved by FDA on Apr 15, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2026 | Original application | Approved | None posted |
| Sodium Bicarbonate5MEQ/10ML (0.5MEQ/ML) · solution;intravenous | Sodium Bicarbonate | Rx |
| Sodium Bicarbonate10MEQ/10ML (1MEQ/ML) · solution;intravenous | Sodium Bicarbonate | Rx |
| Sodium Bicarbonate50MEQ/50ML (1MEQ/ML) · solution;intravenous | Sodium Bicarbonate | 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
