POTASSIUM CHLORIDE | A074726 | UPSHER SMITH LABORATORIES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizens Petition Approval letter to Robert Dormer and Gordon Johnston FDA-2014-P-1657 · 4 docket documents Robert Dormer and Gordon Johnston filed citizen petitions requesting that the FDA designate K-Tab (potassium chloride extended-release tablets, USP), 20 mEq, approved under NDA 18279 and marketed by Abbvie, as a reference listed drug in the Orange Book to enable submission of abbreviated new drug ap | 505(q) | 2014-11-13 | GrantedNo FDA response document on docket | — |
Citizen Petition From Hyman, Phelps & McNamara , P.C. FDA-2014-P-0328 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that FDA designate K-Tab (potassium chloride extended release tablets, USP, 20 meq., NDA No. 18279) as a Reference Listed Drug in the Orange Book to allow generic applicants to submit ANDAs referencing this product, since the curr | 505(q) | 2014-03-28 | GrantedUnverified summary | Hyman, Phelps & McNamara , P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4958
per ea
Lowest NADAC/Unit
$0.1296
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00245531811KLOR-CON M15 TABLET | $0.4958 | EA | — | — | 2026-08-19 |
| 00245531801KLOR-CON M15 TABLET | $0.4958 | EA | — | — | 2026-08-19 |
| 00245531710KLOR-CON M10 TABLET | $0.1566 | EA | — | $0.1296 | 2026-08-19 |
| 00245531790KLOR-CON M10 TABLET | $0.1566 | EA | — | $0.1296 | 2026-08-19 |
| 00245531711KLOR-CON M10 TABLET | $0.1566 | EA | — | $0.1296 | 2026-08-19 |
| 00245531701KLOR-CON M10 TABLET | $0.1566 | EA | — | $0.1296 | 2026-08-19 |
Showing 6 of 16 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.