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FDA NDA · NDA207078

LOKELMA

sodium zirconium cyclosilicate

Sponsor: ASTRAZENECA

APPLICATION
NDA207078
TYPE
NDA
ORIGINAL APPROVAL
2018-05-18
LATEST ACTION
2024-02-08
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

LOKELMA · ReferencePrescription
SODIUM ZIRCONIUM CYCLOSILICATE 5GM/PACKET · FOR SUSPENSION · ORAL
LOKELMA · ReferencePrescription
SODIUM ZIRCONIUM CYCLOSILICATE 10GM/PACKET · FOR SUSPENSION · ORAL

Approval history

2024-02-08Labeling · Supplement 10 · standard — Letter ↗AP
2022-09-30Labeling · Supplement 8 · standard — Letter ↗AP
2021-10-19Labeling · Supplement 7 · standard — Label ↗AP
2020-04-24Efficacy · Supplement 3 · standard — Label ↗AP
2018-05-18Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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