DICLOFENAC SODIUM | A074394 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Yiling Pharmaceutical Ltd FDA-2018-P-2901 Yiling Pharmaceutical Ltd filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA select a different listed drug as the reference standard for VOLTAREN diclofenac sodium delayed-release tablets in 75mg, 50mg, and 25mg strengths to be used in conducting in vivo bioequivale | 505(q) | 2018-07-27 | Denied | Yiling Pharmaceutical Ltd |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.