NAPROXEN SODIUM | N020353 | TWI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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 |
Citizen Petition From Almatica Pharma, Inc. FDA-2014-P-0407 Almatica Pharma, Inc. filed this citizen petition under Section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require applicants seeking to file ANDAs referencing Naprelan (naproxen sodium extended release tablets), approved under NDA No. 020353, to establish bioequivale | 505(q) | 2014-04-10 | Denied | Almatica Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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