An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	Labeling-Package Insert, Efficacy-Labeling Change With Clinical Data	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	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf
08/29/2018	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf
08/19/2014	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	212425	APOTEX
ELIGLUSTAT TARTRATE	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	No	AB	212369	CIPLA
ELIGLUSTAT TARTRATE	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE;ORAL	Prescription	No	AB	212420	UPSHER SMITH LABS

Top