NDA 21264, held by Mdd US. Apomorphine Hydrochloride.
As of Nov 14, 2026, NDA 21264 (Apokyn), held by Mdd US, was first approved by FDA on Apr 20, 2004, with 11 approved supplements and 0 published complete response letters.
| Mar 16, 2017 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Apr 20, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Apokyn20MG/2ML (10MG/ML) · injectable;subcutaneous | Apomorphine Hydrochloride | Discontinued |
| Apokyn30MG/3ML (10MG/ML) · injectable;subcutaneous | Apomorphine Hydrochloride | RxReference drug |
| Feb 3, 2025 | Supplement 25Manufacturing · Standard review | Approved | |
| Jun 22, 2022 | Supplement 21Labeling · Standard review | Approved | |
| May 5, 2022 | Supplement 22Labeling · Standard review | Approved | |
| May 1, 2020 | Supplement 18Labeling · Standard review | Approved | |
| Dec 3, 2019 | Supplement 17Labeling · Standard review | Approved | |
| May 20, 2019 | Supplement 16Labeling · Standard review | Approved | |
| Mar 16, 2017 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2014 | Supplement 10Labeling · Standard review | Approved | |
| Sep 2, 2010 | Supplement 9Labeling · Standard review | Approved | |
| Dec 31, 2008 | Supplement 5Labeling · Standard review | Approved | |
| Dec 31, 2008 | Supplement 3Labeling · Standard review | Approved | |
| Apr 20, 2004 | Original applicationNew molecular entity · 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
