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FDA NDA · NDA206814

POKONZA POTASSIUM CHLORIDE

potassium chloride

Sponsor: GENUS LIFESCIENCES

APPLICATION
NDA206814
TYPE
NDA
ORIGINAL APPROVAL
2014-12-22
LATEST ACTION
2026-06-12
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

POKONZA · ReferencePrescription
POTASSIUM CHLORIDE 10MEQ/15ML · SOLUTION · ORAL
POTASSIUM CHLORIDE · ReferencePrescription
POTASSIUM CHLORIDE 20MEQ/15ML · SOLUTION · ORAL
POTASSIUM CHLORIDE · ReferencePrescription
POTASSIUM CHLORIDE 40MEQ/15ML · SOLUTION · ORAL

Approval history

2026-06-12Manufacturing (CMC) · Supplement 13 — Label ↗AP
2020-03-05Labeling · Supplement 9 · standard — Label ↗AP
2019-05-01Manufacturing (CMC) · Supplement 8 · standard — Label ↗AP
2019-02-04Labeling · Supplement 7 · standard — Letter ↗AP
2015-07-14Manufacturing (CMC) · Supplement 1 · standardAP
2014-12-22Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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