DICLOFENAC SODIUM | N022122 | HALEON US HOLDINGS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Laboflex, Inc. FDA-2025-P-4911 · 10 docket documents Laboflex, Inc. submitted this ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the FDC Act and 21 C.F.R. § 314.93, requesting FDA confirmation that Diclofenac Sodium Plaster 1% is suitable for submission in an Abbreviated New Drug Application. The proposed plaster dosage form differs fr | Suitability | 2025-10-08 | Denied | Laboflex, Inc. |
Citizen Petition from Wiley Rein, LLP FDA-2020-P-1237 · 6 docket documents Wiley Rein LLP filed this citizen petition on March 30, 2020, requesting that FDA withdraw or rescind approval of supplemental NDA 22122/S-14 for Voltaren Arthritis Pain (diclofenac sodium topical gel 1%), which was approved for over-the-counter status on February 14, 2020. The petitioner contends t | 505(q) | 2020-04-01 | Withdrawn | Wiley Rein, LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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