NDA 20559, held by Glaxosmithkline. Ranitidine Bismuth Citrate.
As of Nov 14, 2026, NDA 20559 (Tritec), held by Glaxosmithkline, was not approved, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 1998 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tritec400MG · tablet;oral | Ranitidine Bismuth Citrate | 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