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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 216811


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NDA 216811 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 216811
Tradename:ICOSAPENT ETHYL
Applicant:Ascent Pharms Inc
Ingredient:icosapent ethyl
Patents:0
Suppliers and Packaging for NDA: 216811
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 216811 ANDA Camber Pharmaceuticals, Inc. 31722-298 31722-298-24 240 CAPSULE in 1 BOTTLE (31722-298-24)
ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 216811 ANDA Camber Pharmaceuticals, Inc. 31722-299 31722-299-12 120 CAPSULE in 1 BOTTLE (31722-299-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Dec 7, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1GM
Approval Date:Feb 16, 2024TE:ABRLD:No

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