MIFEPRISTONE | A216616 | EVITA SOLUTIONS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Students for Life of America FDA-2025-P-5436 · 3 docket documents Students for Life of America filed this citizen petition under 21 C.F.R. § 10.30 and Section 505 of the Food, Drug and Cosmetic Act requesting that the FDA revoke its approval of Abbreviated New Drug Application 216616 for a generic version of mifepristone and modify the associated regimen and Risk | Other | 2025-10-17 | Open | Students for Life of America |
Citizen Petition from Students for Life of America FDA-2025-P-5437 · 3 docket documents Students for Life of America filed this citizen petition under 21 C.F.R. § 10.30 and Section 505 of the Food, Drug and Cosmetic Act requesting that the FDA revisit the approval of Abbreviated New Drug Application 216616 for a generic version of Mifepristone and require that all Mifepristone prescrip | 505(q) | 2025-10-17 | Open | Students for Life of America |
Citizen Petition from Students for Life of America FDA-2025-P-5434 · 3 docket documents Students for Life of America filed this citizen petition under 21 C.F.R. § 10.30 and Section 313 of the Clean Water Act to request that the FDA revoke approval of Abbreviated New Drug Application 216616, a generic version of Mifepristone, claiming the FDA has failed to comply with state water qualit | 505(q) | 2025-10-17 | Open | Students for Life of America |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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