MEPROBAMATE | A084153 | ACELLA PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Acella Pharmaceuticals, LLC FDA-2020-P-1919 Acella Pharmaceuticals, LLC filed this citizen petition on September 16, 2020, requesting that the FDA Commissioner determine a new Reference Standard for Meprobamate Tablets, 400 mg under ANDA 084153 because the reference listed drug from Watson Labs is no longer available on the market and no diss | 505(q) | 2020-09-17 | Withdrawn | Acella Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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