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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 Par Pharm Inc, Teva Pharms Usa, Amneal Pharms, and Apotex Inc, and is included in four NDAs. It is available from twelve 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. Eighteen suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

Summary for NDA: 091028

Tradename:
OMEGA-3-ACID ETHYL ESTERS
Applicant:
Teva Pharms Usa
Ingredient:
omega-3-acid ethyl esters
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091028

Ingredient-typeFatty Acids, Omega-3

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 Teva Pharmaceuticals USA Inc 0093-5401 0093-5401-89 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-5401-89)

Summary 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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