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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 091028


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NDA 091028 describes OMEGA-3-ACID ETHYL ESTERS, which is a drug marketed by Amneal Pharms, Apotex, Ascent Pharms Inc, Bionpharma, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Slayback Pharma Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, and Zydus, 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.
Summary for 091028
Tradename:OMEGA-3-ACID ETHYL ESTERS
Applicant:Glw
Ingredient:omega-3-acid ethyl esters
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091028
Suppliers and Packaging for NDA: 091028
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 091028 ANDA Golden State Medical Supply, Inc. 51407-763 51407-763-12 120 CAPSULE in 1 BOTTLE, PLASTIC (51407-763-12)
OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 091028 ANDA KD Pharma USA, Inc. 72998-851 72998-851-12 120 CAPSULE in 1 BOTTLE, PLASTIC (72998-851-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:Apr 7, 2014TE:ABRLD:No

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