NDA 21369, held by Lannett Co Inc. Chlorpheniramine Polistirex; Codeine Polistirex.
As of Nov 14, 2026, NDA 21369 (Codeprex), held by Lannett Co Inc, was first approved by FDA on Jun 21, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CodeprexEQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML · suspension, extended release;oral | Chlorpheniramine Polistirex; Codeine Polistirex | 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
