ANDA 72517, held by Marsam Pharms LLC. Haloperidol Lactate.
As of Nov 15, 2026, ANDA 72517 (Haloperidol), held by Marsam Pharms LLC, was first approved by FDA on Feb 25, 1993, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| HaloperidolEQ 5MG BASE/ML ยท injectable;injection | Haloperidol Lactate | Discontinued |
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
