Treats schizophrenia. ANDA 219168, held by Caplin. Haloperidol Decanoate.
As of Nov 14, 2026, ANDA 219168 (Haloperidol Decanoate), held by Caplin, was first approved by FDA on May 13, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2025 | 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 |
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
