Treats schizophrenia. ANDA 214507, held by Meitheal. Haloperidol Decanoate.
As of Nov 14, 2026, ANDA 214507 (Haloperidol Decanoate), held by Meitheal, was first approved by FDA on Jul 26, 2021, with 2 approved supplements and 0 published complete response letters.
Haloperidol Decanoate Injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2021 | Original application | Approved | None posted |
| Haloperidol DecanoateEQ 50MG BASE/ML · injectable;injection | Haloperidol Decanoate | Rx |
| Haloperidol DecanoateEQ 100MG BASE/ML · injectable;injection | Haloperidol Decanoate | Rx |
| Jun 25, 2026 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 12, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 26, 2021 | Original application | Approved | None posted |
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
