ANDA 208197, held by Hikma. Droperidol.
As of Nov 15, 2026, ANDA 208197 (Droperidol), held by Hikma, was first approved by FDA on Dec 14, 2017, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Droperidol Injection, USP is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 14, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Droperidol2.5MG/ML · injectable;injection | Droperidol | 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
