NDA 17941, held by Glaxosmithkline. Pseudoephedrine Hydrochloride.
As of Nov 13, 2026, NDA 17941 (Sudafed 12 Hour), held by Glaxosmithkline, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Sudafed 12 Hour120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ยท capsule, extended release;oral | Pseudoephedrine Hydrochloride | DiscontinuedReference drug |
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
