Relieves cough and upper respiratory symptoms associated with allergy or the common cold. NDA 206323, held by Mainpointe. Chlorpheniramine Maleate; Codeine Phosphate.
As of Nov 14, 2026, NDA 206323 (Tuxarin Er), held by Mainpointe, was first approved by FDA on Jun 22, 2015, with 6 approved supplements and 0 published complete response letters.
TUXARIN ER is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 22, 2015 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tuxarin Er8MG;54.3MG · tablet, extended release;oral | Chlorpheniramine Maleate; Codeine Phosphate | Rx |
| Jul 10, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 8Labeling · Standard review | Approved | |
| Jun 28, 2018 | Supplement 6Labeling · Standard review | Approved | |
| Aug 29, 2017 | Supplement 5Labeling · Standard review | Approved | |
| Jan 13, 2017 | Supplement 4Labeling · Standard review | Approved | |
| Aug 25, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Jun 22, 2015 | Original applicationNew combination · Standard review | Approved |
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
