CLONAZEPAM | N020813 | HOFFMANN LA ROCHE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services, Inc. FDA-2003-P-0122 · 8 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Clonazepam Oral Solution, 1 mg per 5 mL suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, with Klonopin Tabl | Other | 2023-02-24 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from Emily Robin et al FDA-2010-P-0091 · 6 docket documents Emily Robin and other individuals who experienced adverse reactions to benzodiazepines filed this petition requesting that the FDA amend labeling for all FDA-approved benzodiazepines, including Ativan (lorazepam), Xanax (alprazolam), Klonopin (clonazepam), and Valium (diazepam), to standardize warni | Other | 2010-03-01 | Denied | Emily Robin et al |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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