NDA 18928, held by Fisons. Chlorpheniramine Polistirex; Codeine Polistirex.
As of Nov 13, 2026, NDA 18928 (Penntuss), held by Fisons, was not approved, with 2 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| PenntussEQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML ยท suspension, extended release;oral | Chlorpheniramine Polistirex; Codeine Polistirex | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 1987 | Supplement 5Labeling | Approved | None posted |
| May 28, 1986 | Supplement 3Labeling | 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