Treats insulin hypoglycemia (hyperinsulinemia or insulin shock). NDA 19445, held by Hospira. Dextrose.
As of Nov 14, 2026, NDA 19445 (Dextrose 50%, Dextrose 25%), held by Hospira, was first approved by FDA on Jun 3, 1986, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE 50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to ensure proper utilization of dextrose and avoid production of hyperglycemia.
| Nov 23, 1998 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | None posted |
| Nov 23, 1998 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 3, 1986 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Jul 25, 2025 | Supplement 43Labeling · Standard review | Approved | |
| Jul 25, 2025 | Supplement 49Labeling · Standard review | Approved | |
| Nov 23, 1998 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | None posted |
| Nov 23, 1998 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 3, 1986 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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
