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FDA NDA · NDA208019

POTASSIUM CHLORIDE

Sponsor: GENUS

APPLICATION
NDA208019
TYPE
NDA
ORIGINAL APPROVAL
2015-08-19
LATEST ACTION
2025-11-12
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

POKONZA · ReferencePrescription
POTASSIUM CHLORIDE 15MEQ · FOR SOLUTION · ORAL
POKONZA · ReferencePrescription
POTASSIUM CHLORIDE 10MEQ · FOR SOLUTION · ORAL
POTASSIUM CHLORIDE · ReferenceDiscontinued
POTASSIUM CHLORIDE 40MEQ · FOR SOLUTION · ORAL
POTASSIUM CHLORIDE · ReferencePrescription
POTASSIUM CHLORIDE 20MEQ · FOR SOLUTION · ORAL

Approval history

2025-11-12Manufacturing (CMC) · Supplement 8 — Label ↗AP
2020-03-05Labeling · Supplement 3 · standard — Label ↗AP
2019-07-10Labeling · Supplement 2 · standard — Letter ↗AP
2015-08-19Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗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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