NDA 207621, held by Pfizer. Naltrexone Hydrochloride; Oxycodone Hydrochloride.
As of Nov 14, 2026, NDA 207621 (Troxyca Er), held by Pfizer, was first approved by FDA on Aug 19, 2016, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2016 | Original applicationTYPE 3/4 · Standard review | Approved |
| Troxyca Er1.2MG;10MG · capsule, extended release;oral | Naltrexone Hydrochloride; Oxycodone Hydrochloride | Discontinued |
| Troxyca Er2.4MG;20MG · capsule, extended release;oral | Naltrexone Hydrochloride; Oxycodone Hydrochloride | Discontinued |
| Troxyca Er3.6MG;30MG · capsule, extended release;oral | Naltrexone Hydrochloride; Oxycodone Hydrochloride | Discontinued |
| Troxyca Er4.8MG;40MG · capsule, extended release;oral | Naltrexone Hydrochloride; Oxycodone Hydrochloride | Discontinued |
| Troxyca Er7.2MG;60MG · capsule, extended release;oral | Naltrexone Hydrochloride; Oxycodone Hydrochloride | Discontinued |
| Troxyca Er9.6MG;80MG · capsule, extended release;oral | Naltrexone Hydrochloride; Oxycodone Hydrochloride | Discontinued |
| May 26, 2017 | Supplement 5REMS | Approved | |
| Dec 16, 2016 | Supplement 4Labeling · Standard review | Approved | |
| Sep 30, 2016 | Supplement 1REMS | Approved | |
| Aug 19, 2016 | Original applicationTYPE 3/4 · 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
