Treats schizophrenia. ANDA 75689, held by Fresenius Kabi USA. Haloperidol Lactate.
As of Nov 15, 2026, ANDA 75689 (Haloperidol), held by Fresenius Kabi USA, was first approved by FDA on Mar 9, 2001, with 13 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Haloperidol injection is indicated for the treatment of patients with schizophrenia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| HaloperidolEQ 5MG BASE/ML · injectable;injection | Haloperidol Lactate | Rx |
| Jan 22, 2025 | Supplement 29Labeling · Standard review | Approved | None posted |
| Jan 13, 2025 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jan 13, 2025 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jun 8, 2018 | Supplement 20Labeling · Standard review | Approved | None posted |
| Sep 15, 2015 | Supplement 19Labeling · Standard review | Approved | None posted |
| Sep 15, 2015 | Supplement 15Labeling | Approved | None posted |
| Sep 27, 2011 | Supplement 14Labeling | Approved | None posted |
| Dec 6, 2010 | Supplement 12Labeling | Approved | None posted |
| Mar 14, 2009 | Supplement 10Labeling | Approved | None posted |
| Oct 30, 2008 | Supplement 9Labeling | Approved | None posted |
| Dec 5, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Oct 7, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Jun 24, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Mar 9, 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
