ANDA 75176, held by Hospira. Haloperidol Decanoate.
As of Nov 14, 2026, ANDA 75176 (Haloperidol Decanoate), held by Hospira, was first approved by FDA on Feb 9, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 2000 | Original application | Approved |
| Haloperidol DecanoateEQ 50MG BASE/ML · injectable;injection | Haloperidol Decanoate | Discontinued |
| Haloperidol DecanoateEQ 100MG BASE/ML · injectable;injection | Haloperidol Decanoate | 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