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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202057
Company: AMARIN PHARMS

Summary Review

Products on NDA 202057

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VASCEPA	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	AB	Yes	Yes
VASCEPA	ICOSAPENT ETHYL	500MG	CAPSULE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202057

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.html 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
12/13/2019	SUPPL-35	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202057s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202057Orig1s035ltr.pdf
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-Package Insert, Labeling-Container/Carton Labels	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

Labels for NDA 202057

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2019	SUPPL-35	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202057s035lbl.pdf
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s002lbl.pdf
03/20/2013	SUPPL-2	Labeling-Container/Carton Labels	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

Therapeutic Equivalents for NDA 202057

VASCEPA

CAPSULE;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	209437	APOTEX
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	216811	ASCENT PHARMS INC
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	209499	DR REDDYS
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	209457	HIKMA
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	217919	HUMANWELL PURACAP
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	217844	ONESOURCE SPECIALTY
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	218994	PHARMOBEDIENT
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	218899	QILU
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	209525	TEVA PHARMS USA
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	219156	XIAMEN LP PHARM CO
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	217656	ZYDUS LIFESCIENCES
VASCEPA	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	Yes	AB	202057	AMARIN PHARMS

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE;ORAL	Prescription	No	AB	216811	ASCENT PHARMS INC
ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE;ORAL	Prescription	No	AB	209499	DR REDDYS
ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE;ORAL	Prescription	No	AB	209457	HIKMA
ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE;ORAL	Prescription	No	AB	217919	HUMANWELL PURACAP
ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE;ORAL	Prescription	No	AB	217844	ONESOURCE SPECIALTY
ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE;ORAL	Prescription	No	AB	209525	TEVA PHARMS USA
ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE;ORAL	Prescription	No	AB	217656	ZYDUS LIFESCIENCES
VASCEPA	ICOSAPENT ETHYL	500MG	CAPSULE;ORAL	Prescription	Yes	AB	202057	AMARIN PHARMS

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