GALANTAMINE HYDROBROMIDE | N021169 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alpha Cognition USA, Inc FDA-2020-P-2301 · 4 docket documents Alpha Cognition USA, Inc., the U.S. Agent for Alpha Cognition, Inc., filed this citizen petition on December 10, 2020, requesting that the FDA designate an additional reference standard for Galantamine Hydrobromide Oral Tablets under section 505(b)(2) of the FD&C Act, as the current Reference Listed | 505(q) | 2020-12-16 | Granted | Alpha Cognition USA, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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