Details for New Drug Application (NDA): 212504
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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 212504
Tradename: | OMEGA-3-ACID ETHYL ESTERS |
Applicant: | Glw |
Ingredient: | omega-3-acid ethyl esters |
Patents: | 0 |
Suppliers and Packaging for NDA: 212504
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 | 212504 | ANDA | KD Pharma USA, Inc. | 72998-850 | 72998-850-12 | 120 CAPSULE in 1 BOTTLE, PLASTIC (72998-850-12) |
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: | Aug 19, 2020 | TE: | AB | RLD: | No |
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