DONEPEZIL HYDROCHLORIDE | N022568 | EISAI INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Public Citizen's Health Research Group - Citizen Petition FDA-2011-P-0455 · 4 docket documents Public Citizen's Health Research Group filed this citizen petition under 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30, requesting that the FDA immediately remove the 23 milligram dose of Aricept (donepezil) from the market because the drug failed to meet the two required co-primary efficacy endpo | 505(q) | 2011-06-09 | Denied | — |
Eisai, Inc., (Hogan Lovells US LLP) - Citizen Petition FDA-2010-P-0430 · 15 docket documents Eisai, Inc., filed this citizen petition under 21 USC 355(q) requesting that the FDA revoke final approval of Teva Pharmaceuticals' ANDA 77-344 for donepezil hydrochloride (Aricept) and restore it to tentative approval status, arguing that Teva improperly obtained final approval through the agency's | 505(q) | 2010-08-19 | Partially Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2007-P-0343 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Donepezil Hydrochloride Orally Dissolving Film Strips in 5 mg and 10 mg strengths suitable for consideration in an abbreviated new drug application (ANDA), with Aricept ODT (donepezil hydrochl | Other | 2008-05-22 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8481565 | Oct 4, 2026 | — | — | Yes | — | — |