DICLOFENAC POTASSIUM | A075463 | RK PHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-4134 · 11 docket documents 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 | Denied | Pharmobedient Consulting, LLC |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4282 · 12 docket documents 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 | Denied | Pharmobedient Consulting, LLC |
Suitability Petition from Pharmobedient Consulting, LLC (on behalf of Amici P... FDA-2022-P-0052 · 9 docket documents 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for Diclofenac Potassium Orally Disintegrating Tablets in 25 mg and 50 mg strengths, wh | Suitability | 2022-01-06 | Withdrawn | Amici Pharmaceuticals LLC |
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2018-P-4661 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition regarding Diclofenac Potassium Tablets, 50 mg, requesting that FDA designate ANDA 075219 as a new reference standard in the Orange Book because the current reference standard approved under ANDA 075463 is commercially unavailable due to manu | 505(q) | 2018-12-07 | Denied | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0998
per ea
Lowest NADAC/Unit
$0.0998
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 72819015110DICLOFENAC POT 50 MG TABLET | $0.0998 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.