Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202057
Company: AMARIN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VASCEPA ICOSAPENT ETHYL 1GM CAPSULE;ORAL Prescription None Yes Yes
VASCEPA ICOSAPENT ETHYL 500MG 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
07/26/2012 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202057S000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202057Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057_vascepa_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2017 SUPPL-19 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202057s019lbl.pdf
01/25/2016 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/28/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/02/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/04/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/23/2015 SUPPL-12 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202057s012lbl.pdf
10/16/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/14/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/25/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s009ltr.pdf
02/26/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/28/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/13/2014 SUPPL-6 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202057Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202057Orig1s006ltr.pdf
04/19/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/12/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/20/2013 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s002lbl.pdf
01/31/2013 SUPPL-1 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/16/2017 SUPPL-19 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202057s019lbl.pdf
06/23/2015 SUPPL-12 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202057s012lbl.pdf
02/13/2014 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202057Orig1s006lbl.pdf
11/25/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s009lbl.pdf
03/20/2013 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s002lbl.pdf
03/20/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s002lbl.pdf
07/26/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202057S000lbl.pdf

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