Manages manifestations of psychotic disorders. ANDA 218371, held by Rubicon Research. Haloperidol Lactate.
As of Nov 15, 2026, ANDA 218371 (Haloperidol), held by Rubicon Research, was first approved by FDA on Jan 31, 2024, with 1 approved supplement 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 |
|---|---|---|---|
| Jan 31, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| HaloperidolEQ 2MG BASE/ML · concentrate;oral | Haloperidol Lactate | Rx |
| Jan 22, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 31, 2024 | 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
