NDA 204442, held by Reacx Pharms. Buprenorphine Hydrochloride.
As of Nov 14, 2026, NDA 204442 (Probuphine), held by Reacx Pharms, was first approved by FDA on May 26, 2016, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 2016 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ProbuphineEQ 80MG BASE/IMPLANT · implant;implantation | Buprenorphine Hydrochloride | DiscontinuedReference drug |
| Dec 22, 2025 | Supplement 15Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 14Labeling · Standard review | Approved | |
| Mar 23, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Jun 17, 2022 | Supplement 12Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 11Labeling · Standard review | Approved | |
| Oct 7, 2019 | Supplement 9Labeling · Standard review | Approved | |
| Nov 1, 2018 | Supplement 7REMS | Approved | |
| Feb 1, 2018 | Supplement 6Labeling · Standard review | Approved | |
| Jul 28, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Jul 28, 2017 | Supplement 4Manufacturing · Standard review | Approved | |
| Apr 19, 2017 | Supplement 3REMS | Approved | |
| May 26, 2016 | Original applicationNew dosage form · Priority 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
