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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 209457


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NDA 209457 describes ICOSAPENT ETHYL, which is a drug marketed by Apotex, Ascent Pharms Inc, Dr Reddys, Hikma, Humanwell Puracap, Strides Pharma, Teva Pharms Usa, and Zydus, and is included in eight NDAs. It is available from thirteen suppliers. 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. Fourteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
Summary for 209457
Tradename:ICOSAPENT ETHYL
Applicant:Hikma
Ingredient:icosapent ethyl
Patents:0
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)
ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209457 ANDA Hikma Pharmaceuticals USA Inc. 0054-0621 0054-0621-27 240 CAPSULE in 1 BOTTLE (0054-0621-27)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Mar 8, 2023TE:ABRLD:No

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