NDA 9925, held by Astrazeneca. Dyclonine Hydrochloride.
As of Nov 13, 2026, NDA 9925 (Dyclone), held by Astrazeneca, was not approved, with 0 approved supplements and 0 published complete response letters.
| Dyclone1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;topical | Dyclonine Hydrochloride | DiscontinuedReference drug |
| Dyclone0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;topical | Dyclonine Hydrochloride | DiscontinuedReference drug |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
