Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205494
Company: GENZYME CORP

• Medication Guide

• Summary Review

Products on NDA 205494

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CERDELGA	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205494

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205494Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205494Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2018	SUPPL-3	Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205494Orig1s003ltr.pdf
05/11/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/05/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205494

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2018	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf
08/29/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf
08/19/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205494Orig1s000lbl.pdf

Therapeutic Equivalents for NDA 205494

CERDELGA

CAPSULE;ORAL; EQ 84MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CERDELGA	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	205494	GENZYME CORP
ELIGLUSTAT TARTRATE	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	No	AB	212463	AIZANT
ELIGLUSTAT TARTRATE	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	No	AB	212420	UPSHER SMITH LABS