Details for New Drug Application (NDA): 217844
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NDA 217844 describes ICOSAPENT ETHYL, which is a drug marketed by Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Humanwell Puracap, Onesource Specialty, Qilu, Teva Pharms Usa, Torrent, Xiamen Lp Pharm Co, and Zydus Lifesciences, and is included in twelve NDAs. It is available from eighteen 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
Summary for 217844
| Tradename: | ICOSAPENT ETHYL |
| Applicant: | Onesource Specialty |
| Ingredient: | icosapent ethyl |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217844
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 217844 | ANDA | Amneal Pharmaceuticals LLC | 69238-2597 | 69238-2597-7 | 240 CAPSULE in 1 BOTTLE (69238-2597-7) |
| ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 217844 | ANDA | Amneal Pharmaceuticals LLC | 69238-2598 | 69238-2598-8 | 120 CAPSULE in 1 BOTTLE (69238-2598-8) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Sep 22, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1GM | ||||
| Approval Date: | Sep 22, 2023 | TE: | AB | RLD: | No | ||||
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