NAPROXEN | N017581 | ATNAHS PHARMA US LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 Draft Label for Naproxen Suspension 50mg/mL re Suitability Petit... FDA-2021-P-0340 Drug Device Consulting LLC filed a citizen petition requesting that the FDA determine the suitability of a draft label for naproxen suspension 50 mg/mL formulation. The petition seeks FDA review and approval of the proposed labeling for this over-the-counter or prescription naproxen suspension produ | Suitability | 2021-03-30 | Granted | Drug Device Consulting LLC |
Attachment 3 RLD Label for Naproxen Suspension 25mg/mL re Suitability Petitio... FDA-2021-P-0340 Drug Device Consulting LLC filed a citizen petition regarding the suitability of the reference listed drug (RLD) label for Naproxen Suspension 25 mg/mL. The petition appears to challenge or question the appropriateness of the existing RLD labeling for this naproxen suspension formulation. | Suitability | 2021-03-30 | Granted | Drug Device Consulting LLC |
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 | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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