Treats schizophrenia. ANDA 209101, held by Somerset Theraps LLC. Haloperidol Decanoate.
As of Nov 14, 2026, ANDA 209101 (Haloperidol Decanoate), held by Somerset Theraps LLC, was first approved by FDA on Jul 3, 2018, with 7 approved supplements and 0 published complete response letters.
Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 3, 2018 | Original application | Approved | None posted |
| Haloperidol DecanoateEQ 50MG BASE/ML · injectable;injection | Haloperidol Decanoate | Rx |
| Haloperidol DecanoateEQ 100MG BASE/ML · injectable;injection | Haloperidol Decanoate | Rx |
| Nov 12, 2021 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 12, 2021 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 12, 2021 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 12, 2021 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 12, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 4, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 4, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 3, 2018 | 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
