← FDA DRUG APPROVALS

FDA NDA · NDA218230

BLUJEPA

gepotidacin

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA218230
TYPE
NDA
ORIGINAL APPROVAL
2025-03-25
LATEST ACTION
2025-12-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BLUJEPA · ReferencePrescription
GEPOTIDACIN MESYLATE EQ 750MG BASE · TABLET · ORAL

Approval history

2025-12-11Efficacy · Supplement 1 · priorityLabelAP
2025-03-25Type 1 - New Molecular Entity · Original · priorityLabelAP
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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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