NAPROXEN SODIUM | N018164 | ATNAHS PHARMA US LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Petition for Stay of Action from Elan Pharmaceuticals FDA-1998-P-0829 Elan Pharmaceuticals submitted this petition on December 15, 1998, requesting that the Food and Drug Administration stay approval of any abbreviated new drug application referencing Naprelan, a controlled release naproxen sodium product, pending FDA action on a companion citizen petition requiring A | 505(q) Stay Request | 2016-12-02 | Denied | — |
Citizen Petition from Elan Pharmaceuticals FDA-1998-P-0829 Elan Pharmaceuticals filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act on December 15, 1998, requesting that the FDA require abbreviated new drug applications (ANDAs) for controlled release naproxen sodium products referencing Naprelan include additional ph | 505(q) | 2016-12-01 | Denied | Elan Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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