Details for New Drug Application (NDA): 215458
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NDA 215458 describes OMEGA-3-ACID ETHYL ESTERS, which is a drug marketed by Amneal Pharms, Apotex, Ascent Pharms Inc, Chartwell, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, Wilshire Pharms Inc, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from twenty-two suppliers. Additional details are available on the OMEGA-3-ACID ETHYL ESTERS profile page.
The generic ingredient in OMEGA-3-ACID ETHYL ESTERS is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.
The generic ingredient in OMEGA-3-ACID ETHYL ESTERS is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.
Summary for 215458
| Tradename: | OMEGA-3-ACID ETHYL ESTERS |
| Applicant: | Mankind Pharma |
| Ingredient: | omega-3-acid ethyl esters |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215458
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 215458 | ANDA | Lifestar Pharma LLC | 70756-423 | 70756-423-22 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (70756-423-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | ||||
| Approval Date: | Nov 15, 2021 | TE: | AB | RLD: | No | ||||
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