Treats schizophrenia. ANDA 75305, held by Hikma. Haloperidol Decanoate.
As of Nov 14, 2026, ANDA 75305 (Haloperidol Decanoate), held by Hikma, was first approved by FDA on Sep 28, 1998, with 10 approved supplements and 0 published complete response letters.
HALOPERIDOL DECANOATE 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 |
|---|---|---|---|
| Sep 28, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Haloperidol DecanoateEQ 100MG BASE/ML · injectable;injection | Haloperidol Decanoate | Rx |
| Apr 26, 2023 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 18, 2019 | Supplement 22Manufacturing | Approved | None posted |
| Sep 27, 2011 | Supplement 17Labeling | Approved | None posted |
| Sep 27, 2011 | Supplement 15Labeling | Approved | None posted |
| Jan 29, 2010 | Supplement 13Labeling | Approved | None posted |
| Nov 19, 2008 | Supplement 12Labeling | Approved | None posted |
| Jun 18, 2008 | Supplement 11Labeling | Approved | None posted |
| Feb 4, 2008 | Supplement 10Labeling | Approved | None posted |
| Oct 16, 2001 | Supplement 1Labeling | Approved | None posted |
| Apr 3, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Sep 28, 1998 | Original application | 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
