DROPERIDOL | A072123 | AMERICAN REGENT INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Anthea Pharma Private Limited FDA-2025-P-5430 · 6 docket documents Anthea Pharma Private Limited filed this citizen petition requesting that the FDA Commissioner determine whether INAPSINE (droperidol) Injection, 2.5 mg/mL, approved under NDA N016796 and held by Rising Pharma Holdings Inc, was withdrawn from sale for safety or effectiveness reasons. The petitioner | Other | 2025-10-16 | Denied | Anthea Pharma Private Limited |
Citizen Petition from Regulatory Affairs Consulting FDA-2025-P-0253 · 5 docket documents Robert van Osdel, a regulatory affairs consultant, filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine whether the reference listed drug Inapsine Injection 2.5 mg/mL (droperidol, N016796) was withdrawn from marketing for | 505(q) | 2025-01-17 | Granted | Regulatory Affairs Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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