Manages manifestations of psychotic disorders. ANDA 73037, held by Pharm Assoc. Haloperidol Lactate.
As of Nov 14, 2026, ANDA 73037 (Haloperidol), held by Pharm Assoc, was first approved by FDA on Feb 26, 1993, with 10 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 |
|---|---|---|---|
| Feb 26, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| HaloperidolEQ 2MG BASE/ML · concentrate;oral | Haloperidol Lactate | Rx |
| Jan 22, 2025 | Supplement 22Labeling · Standard review | Approved | None posted |
| Feb 23, 2017 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 3, 2010 | Supplement 14Labeling | Approved | None posted |
| Aug 18, 2010 | Supplement 13Labeling | Approved | None posted |
| Feb 26, 2010 | Supplement 12Labeling | Approved | None posted |
| Mar 12, 2009 | Supplement 11Labeling | Approved | None posted |
| Nov 25, 2008 | Supplement 10Labeling | Approved | None posted |
| Mar 27, 1995 | Supplement 4Manufacturing | Approved | None posted |
| Jan 31, 1995 | Supplement 3Labeling | Approved | None posted |
| Jan 31, 1995 | Supplement 2Manufacturing | Approved | None posted |
| Feb 26, 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
