NDA 201194, held by Vistapharm LLC. Oxycodone Hydrochloride.
As of Nov 13, 2026, NDA 201194 (Oxycodone Hydrochloride), held by Vistapharm LLC, was first approved by FDA on Jan 12, 2012, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 21, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jan 12, 2012 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxycodone Hydrochloride5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;oral | Oxycodone Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2026 | Supplement 22REMS | Approved | |
| Dec 22, 2025 | Supplement 21Labeling · Standard review | Approved | |
| Oct 31, 2024 | Supplement 20REMS | Approved | |
| Apr 19, 2024 | Supplement 19Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 17Labeling · Standard review | Approved | |
| Jul 21, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Mar 4, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Oct 7, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 4Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 3REMS | Approved | |
| Dec 16, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Jun 2, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 12, 2012 | Original applicationTYPE 7 · 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
