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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 209437


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NDA 209437 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 Lifesciences, and is included in eight NDAs. It is available from fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
Summary for 209437
Tradename:ICOSAPENT ETHYL
Applicant:Apotex
Ingredient:icosapent ethyl
Patents:0
Suppliers and Packaging for NDA: 209437
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209437 ANDA Apotex Corp 60505-4033 60505-4033-1 120 CAPSULE in 1 BOTTLE (60505-4033-1)
ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209437 ANDA American Health Packaging 60687-764 60687-764-21 30 BLISTER PACK in 1 CARTON (60687-764-21) / 1 CAPSULE in 1 BLISTER PACK (60687-764-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1GM
Approval Date:Jun 30, 2021TE:ABRLD:No

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