DONEPEZIL HYDROCHLORIDE | N212304 | CORIUM LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pilnova Pharma Inc. FDA-2026-P-7916 Pilnova Pharma Inc. filed this citizen petition requesting that FDA withdraw approval of doxorubicin hydrochloride liposomal intravenous infusion and take enforcement action against the current NDA holder on the grounds that the drug's commercial formulation differs from the formulation tested in cl | Other | 2026-07-17 | Open | Pilnova Pharma Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9993466 | Jul 26, 2037 | — | — | Yes | — | — |
| 10016372 | Jul 26, 2037 | — | — | — | — | |
| 10300025 | Jul 26, 2037 | — | — | Yes | — | — |
| 10307379 | Jul 26, 2037 | — | — | Yes | — | — |
| 10835499 | May 20, 2038 | — | — | Yes | — | |
| 10966936 | Aug 11, 2038 | — | — | Yes | — | |
| 11103463 | Jul 26, 2037 | — | — | — | — | |
| 11648214 | Sep 23, 2037 | — | — | Yes | — | |
| 11679086 | May 26, 2037 | — | — | — | — | |
| 12161767 | Dec 30, 2036 | — | Yes | Yes | — | |
| 12168075 | Dec 30, 2036 | — | — | — | — |