DONEPEZIL HYDROCHLORIDE | N021720 | EISAI INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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in an abbreviated new drug application (ANDA), with Aricept ODT (donepezil hydrochl | Other | 2008-05-22 | Withdrawn | — |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.
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