ANDA 204849, held by Epic Pharma LLC. Haloperidol Lactate.
As of Nov 15, 2026, ANDA 204849 (Haloperidol), held by Epic Pharma LLC, was first approved by FDA on Sep 6, 2017, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 6, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| HaloperidolEQ 5MG BASE/ML · injectable;injection | Haloperidol Lactate | Discontinued |
| Jan 22, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 23, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 6, 2017 | 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
