OSILODROSTAT PHOSPHATE | N212801 | RECORDATI RARE DISEASES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Annora Pharma Private Limited FDA-2026-P-4574 · 2 docket documents Annora Pharma Private Limited filed this citizen petition requesting that the FDA determine whether the original formulation of ISTURSIA (osilodrostat) tablets 10 mg, NDA 212801, held by Recordati Rare Diseases Inc., was voluntarily withdrawn for reasons of safety or efficacy, as the product is curr | 505(q) | 2026-04-24 | Open | Annora Pharma Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| ODE-286 | Mar 6, 2027 | < 1 year |
| ODE-535 | Apr 15, 2032 | Active |