DICLOFENAC POTASSIUM | A075219 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093094801DICLOFENAC POT 50 MG TABLET | $0.0998 | EA | Generic | — | 2026-06-17 |
| 00093094805DICLOFENAC 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.