ALBENDAZOLE | A208979 | ZYDUS PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amedra Pharmaceuticals LLC - Citizen Petition FDA-2013-P-0766 · 5 docket documents Amedra Pharmaceuticals LLC filed this citizen petition on June 18, 2013, requesting that the FDA refrain from approving any abbreviated new drug application for a generic version of ALBENZA (albendazole) tablets unless the applicant demonstrates bioequivalence based on systemic levels of the primary | 505(q) | 2013-07-16 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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