Treats schizophrenia. ANDA 75858, held by Hikma. Haloperidol Lactate.
As of Nov 15, 2026, ANDA 75858 (Haloperidol), held by Hikma, was first approved by FDA on Jun 18, 2001, with 14 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Haloperidol is indicated for the treatment of patients with schizophrenia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| HaloperidolEQ 5MG BASE/ML · injectable;injection | Haloperidol Lactate | Rx |
| Jan 22, 2025 | Supplement 28Labeling · Standard review | Approved | None posted |
| Jun 23, 2023 | Supplement 23Labeling · Standard review | Approved | None posted |
| Oct 9, 2019 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jun 8, 2018 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jun 8, 2018 | Supplement 21Labeling · Standard review | Approved | None posted |
| Nov 21, 2016 | Supplement 19Manufacturing | Approved | None posted |
| Nov 10, 2011 | Supplement 14Labeling | Approved | None posted |
| Nov 2, 2011 | Supplement 13Labeling | Approved | None posted |
| Dec 9, 2009 | Supplement 11Labeling | Approved | None posted |
| Nov 19, 2008 | Supplement 10Labeling | Approved | None posted |
| May 29, 2008 | Supplement 9Labeling | Approved | None posted |
| Feb 1, 2008 | Supplement 8Labeling | Approved | None posted |
| Oct 18, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Sep 4, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Jun 18, 2001 | 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
