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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209457
Company: HIKMA

Products on ANDA 209457

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209457

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209457Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 209457

ICOSAPENT ETHYL

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	218899	QILU
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	218994	SPRIASO LLC
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	217844	STRIDES SOFTGELS
ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE;ORAL	Prescription	No	AB	209525	TEVA PHARMS USA
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	STRIDES SOFTGELS
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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