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FDA NDA · NDA209229

LUCEMYRA

lofexidine hydrochloride

Sponsor: BIOCORRX PHARMS

APPLICATION
NDA209229
TYPE
NDA
ORIGINAL APPROVAL
2018-05-16
LATEST ACTION
2024-09-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LUCEMYRA · ReferencePrescription
LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE · TABLET · ORAL

Approval history

2024-09-05Labeling · Supplement 7 · standardLabelAP
2018-05-16Type 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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