ANDA 216228, held by Mylan Pharms Inc. Paliperidone Palmitate.
As of Nov 15, 2026, ANDA 216228 (Paliperidone Palmitate), held by Mylan Pharms Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2024 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Paliperidone Palmitate273MG/0.88ML ยท suspension, extended release;injectable | Paliperidone Palmitate | None (tentative approval) |
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
