Treats motor fluctuations. NDA 214056, held by Mdd US. Apomorphine Hydrochloride.
As of Nov 14, 2026, NDA 214056 (Onapgo), held by Mdd US, was first approved by FDA on Feb 3, 2025, with 2 approved supplements and 0 published complete response letters.
ONAPGO is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Onapgo98MG/20ML (4.9MG/ML) · solution;subcutaneous | Apomorphine Hydrochloride | RxReference drug |
| Jun 30, 2026 | Supplement 6Labeling · Standard review | Approved | |
| May 15, 2026 | Supplement 5Labeling · Standard review | Approved | |
| Feb 3, 2025 | Original applicationNew formulation or manufacturer · 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
