Manages manifestations of psychotic disorders. ANDA 73364, held by Lannett Co Inc. Haloperidol Lactate.
As of Nov 15, 2026, ANDA 73364 (Haloperidol), held by Lannett Co Inc, was first approved by FDA on Sep 28, 1993, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Haloperidol Oral Solution is indicated for use in the management of manifestations of psychotic disorders. Haloperidol Oral Solution is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol Oral Solution is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| HaloperidolEQ 2MG BASE/ML · concentrate;oral | Haloperidol Lactate | Rx |
| Jan 22, 2025 | Supplement 15Labeling · Standard review | Approved | None posted |
| Feb 23, 2017 | Supplement 11Labeling · Standard review | Approved | None posted |
| Dec 3, 2010 | Supplement 9Labeling | Approved | None posted |
| Apr 30, 2009 | Supplement 8Labeling | Approved | None posted |
| Jan 10, 2002 | Supplement 4Labeling | Approved | None posted |
| Sep 22, 2000 | Supplement 3Manufacturing | Approved | None posted |
| Sep 8, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Jul 27, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Sep 28, 1993 | 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
