Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022527
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GILENYA FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription None Yes Yes
GILENYA FINGOLIMOD HYDROCHLORIDE EQ 0.25MG BASE CAPSULE;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/21/2010 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022527s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022527s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022527Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022527Orig1s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/2019 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022527Orig1s029, 022527Orig1s030ltr.pdf
08/16/2019 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022527Orig1s029,%20022527Orig1s030ltr.pdf
10/26/2018 SUPPL-27 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s027lbl.pdf
01/11/2019 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s26lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022527Orig1s026ltr.pdf
05/11/2018 SUPPL-24 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022527Orig1s024ltr.pdf
12/15/2017 SUPPL-22 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022527s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/22527Orig1s022ltr.pdf
11/29/2016 SUPPL-21 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022527Orig1s021ltr.pdf
08/04/2015 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s019ltr.pdf
02/19/2016 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022527s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022527Orig1s018ltr.pdf
07/02/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s016ltr.pdf
05/14/2015 SUPPL-15 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s015ltr.pdf
08/22/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/01/2015 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s013ltr.pdf
05/28/2013 SUPPL-10 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022527Orig1s010ltr.pdf
04/30/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022527s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022527Orig1s009ltr.pdf
05/09/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s008ltr.pdf
03/18/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s006ltr.pdf
03/01/2012 SUPPL-5 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s005ltr.pdf
07/01/2011 SUPPL-3 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s003lbl.pdf
07/20/2011 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022527s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/16/2019 SUPPL-30 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf
08/16/2019 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf
08/16/2019 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf
08/16/2019 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf
01/11/2019 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s26lbl.pdf
10/26/2018 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s027lbl.pdf
05/11/2018 SUPPL-24 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s024lbl.pdf
12/15/2017 SUPPL-22 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022527s022lbl.pdf
02/19/2016 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022527s018lbl.pdf
02/19/2016 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022527s018lbl.pdf
08/04/2015 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s019lbl.pdf
07/02/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s016lbl.pdf
05/01/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s013lbl.pdf
04/30/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022527s009lbl.pdf
05/09/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008lbl.pdf
03/18/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s006lbl.pdf
07/20/2011 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s002lbl.pdf
07/01/2011 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s003lbl.pdf
09/21/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022527s000lbl.pdf

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