CLORAZEPATE DIPOTASSIUM | N017105 | AJENAT PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Granules Pharmaceuticals Inc FDA-2017-P-5799 Granules Pharmaceuticals Inc. submitted this Section 505(j) citizen petition requesting that FDA designate Mylan Pharmaceuticals' ANDA 071858 for Clorazepate Dipotassium Tablets 15 mg as an alternative reference standard for developing an ANDA, because the current reference standard TRANXENE Cloraze | Other | 2017-09-19 | Denied | Granules Pharmaceuticals Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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