Details for New Drug Application (NDA): 217919
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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 217919
Tradename: | ICOSAPENT ETHYL |
Applicant: | Humanwell Puracap |
Ingredient: | icosapent ethyl |
Patents: | 0 |
Suppliers and Packaging for NDA: 217919
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 217919 | ANDA | EPIC PHARMA, LLC | 42806-559 | 42806-559-24 | 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-559-24) |
ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 217919 | ANDA | EPIC PHARMA, LLC | 42806-560 | 42806-560-12 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-560-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Dec 22, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1GM | ||||
Approval Date: | Dec 22, 2023 | TE: | AB | RLD: | No |
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