Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205494
Company: GENZYME CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CERDELGA ELIGLUSTAT TARTRATE EQ 84MG BASE CAPSULE;ORAL Prescription None Yes Yes
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/19/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205494Orig1s000lbl.pdf

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