NDA 22193, held by Alcon Pharms Ltd. Calcium Chloride; Dextrose; Magnesium Chloride; Oxiglutatione; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate.
As of Nov 14, 2026, NDA 22193 (Navstel), held by Alcon Pharms Ltd, was first approved by FDA on Jul 24, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Navstel0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML · solution;irrigation | Calcium Chloride; Dextrose; Magnesium Chloride; Oxiglutatione; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate | 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
