POTASSIUM CHLORIDE | N208019 | GENUS LIFESCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Foley & Lardner LLP (Lehigh Valley Technologies, Inc.) FDA-2016-P-3052 · 8 docket documents Lehigh Valley Technologies, Inc., through counsel at Foley & Lardner LLP, filed a citizen petition requesting that the FDA investigate and take enforcement action against Virtus Pharmaceuticals Holdings LLC and related entities to remove their unapproved drug products, mislabeled dietary supplements | Other | 2016-09-30 | Open | Foley & Lardner LLP (Lehigh Valley Technologies, Inc.) |
Citizen Petition from Buchanan Ingersoll & Rooney PC (Virtus Pharmaceuticals... FDA-2016-P-2029 · 23 docket documents Buchanan Ingersoll & Rooney PC, on behalf of Virtus Pharmaceuticals OpCo, LLC, filed this citizen petition under 505(e) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA institute proceedings to withdraw two New Drug Applications—NDA 208019 for Potassium Chloride for Oral Solution | Other | 2016-07-13 | Denied | Buchanan Ingersoll & Rooney PC (Virtus Pharmaceuticals OpCo, LLC) |
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2015-P-4019 · 4 docket documents The law firm Hyman, Phelps & McNamara filed this October 2015 citizen petition requesting that FDA designate Potassium Chloride for Oral Solution, 20 mEq, approved under NDA 208019 as a Reference Listed Drug to enable generic applicants to submit ANDAs for this drug product, noting that no RLD curre | 505(q) | 2015-11-06 | Granted | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$28.42
per ea
Lowest NADAC/Unit
$0.6307
per ea
Brand NDCs
2
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 15370030530POKONZA 10 MEQ PACKET | $28.42 | EA | Brand | — | 2026-02-26 |
| 15370030560POKONZA 10 MEQ PACKET | $28.42 | EA | Brand | — | 2026-02-26 |
| 00603155404POTASSIUM CL 20 MEQ PACKET | $0.6307 | EA | Generic | — | 2026-06-17 |
| 00603155416POTASSIUM CL 20 MEQ PACKET | $0.6307 | 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.