NDA 50167, held by Glaxosmithkline. Bacitracin Zinc; Polymyxin B Sulfate.
As of Nov 13, 2026, NDA 50167 (Polysporin), held by Glaxosmithkline, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Polysporin10,000 UNITS/GM;2,000,000 UNITS/GM ยท aerosol;topical | Bacitracin Zinc; Polymyxin B Sulfate | 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