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ICOSAPENT ETHYL

ANDA

ICOSAPENT ETHYL | A209525 | TEVA PHARMACEUTICALS USA

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VASCEPA(TE code: AB)

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

FINORGA SASICOSAPENT ETHYL

DMF 271822013

HUATAI PHARMA INCICOSAPENT ETHYL

DMF 349592020

SICHUAN GOWELL PHARMACEUTICAL CO LTDICOSAPENT ETHYL

DMF 358542021

AK BIOPHARM CO LTDICOSAPENT ETHYL

DMF 368222022

KINOMEGA BIOPHARM INCICOSAPENT ETHYL

DMF 390402023

SKUNY BIOSCIENCE CO LTDInactiveICOSAPENT ETHYL

DMF 284222014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 30, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 11, 2020

No patent or exclusivity listings for this strength.

#002 — 1GM

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Sep 11, 2020