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 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.
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 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: | RX | Dosage: | CAPSULE;ORAL | Strength | 1GM | ||||
| Approval Date: | May 21, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Mar 8, 2023 | TE: | AB | RLD: | No | ||||
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