DICLOFENAC SODIUM | A202027 | APOTEX INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2012-08-30 | Terminated 2014-01-28 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from MacLeods Pharmaceuticals Limited FDA-2016-P-3753 MacLeods Pharmaceuticals Limited filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Apotex Inc's approved generic Diclofenac Sodium Topical Solution 1.5% (ANDA #202027) as a reference listed drug, since the original referenc | Other | 2016-11-10 | Denied | MacLeods Pharmaceuticals Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.