Treats hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off"…. ANDA 212025, held by Tp Anda Holdings. Apomorphine Hydrochloride.
As of Nov 15, 2026, ANDA 212025 (Apomorphine Hydrochloride), held by Tp Anda Holdings, was first approved by FDA on Feb 23, 2022, with 0 approved supplements and 0 published complete response letters.
Apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced Parkinson's disease. Apomorphine hydrocloride inejction has been studied as an adjunct to other medications.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Apomorphine Hydrochloride30MG/3ML (10MG/ML) · injectable;subcutaneous | Apomorphine Hydrochloride | Rx |
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
