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Last Updated: May 14, 2021

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Details for New Drug Application (NDA): 209457

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NDA 209457 describes ICOSAPENT ETHYL, which is a drug marketed by Dr Reddys, Hikma, and Teva Pharms Usa, and is included in three NDAs. It is available from one supplier. Additional details are available on the ICOSAPENT ETHYL profile page.

The generic ingredient in ICOSAPENT ETHYL is icosapent ethyl. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
Summary for 209457
Ingredient:icosapent ethyl
Suppliers and Packaging for NDA: 209457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209457 ANDA Hikma Pharmaceuticals USA Inc. 0054-0508 0054-0508-23 120 CAPSULE in 1 BOTTLE (0054-0508-23)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1GM
Approval Date:May 21, 2020TE:ABRLD:No

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