CIPROFLOXACIN HYDROCHLORIDE | N021918 | LABORATORIOS SALVAT SA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Laboratorios SALVAT SA (Fish & Richardson, PC) - Citizen Petition FDA-2012-P-0647 · 3 docket documents Laboratorios SALVAT, S.A., through Fish & Richardson P.C., filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any abbreviated new drug applications for non-sterile otic formulations citing CETRAXAL (ciprofloxacin hydroc | 505(q) | 2012-06-21 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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