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FDA NDA · NDA205494

CERDELGA

eliglustat

Sponsor: GENZYME CORP

APPLICATION
NDA205494
TYPE
NDA
ORIGINAL APPROVAL
2014-08-19
LATEST ACTION
2018-08-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CERDELGA · ReferencePrescription
ELIGLUSTAT TARTRATE EQ 84MG BASE · CAPSULE · ORAL

Approval history

2018-08-29Efficacy · Supplement 3 · standard — Label ↗AP
2015-05-11Manufacturing (CMC) · Supplement 2 · priorityAP
2014-11-05Manufacturing (CMC) · Supplement 1 · priorityAP
2014-08-19Type 1 - New Molecular Entity · Original · priority — Medication Guide ↗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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