DICLOFENAC POTASSIUM | A075463 | RK PHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-4134 Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA declare Diclofenac Potassium Tablets 37.5 mg suitable for submission in an Abbreviated New Drug Application. The proposed produc | Suitability | 2024-08-29 | Open | Pharmobedient Consulting |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4282 Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Diclofenac Potassium Orally Disintegrating Tablets in 25 mg and 50 mg strengths suitable for submission as an Abbreviated New Drug Applica | Suitability | 2023-10-03 | Open | Pharmobedient Consulting |
Suitability Petition from Pharmobedient Consulting, LLC (on behalf of Amici P... FDA-2022-P-0052 Pharmobedient Consulting, LLC, on behalf of Amici Pharmaceuticals LLC, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an ANDA for Diclofenac Potassium Orally Disintegrating Tablets in 25 mg and 50 mg strengths, wh | Suitability | 2022-01-06 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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