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Details for New Drug Application (NDA): 204977

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NDA 204977 describes OMTRYG, which is a drug marketed by Trygg and is included in one NDA. It is available from one supplier. Additional details are available on the OMTRYG profile page.

The generic ingredient in OMTRYG is omega-3-acid ethyl esters type a. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the omega-3-acid ethyl esters type a profile page.

Summary for NDA: 204977

Tradename:
OMTRYG
Applicant:
Trygg
Ingredient:
omega-3-acid ethyl esters type a
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204977

Ingredient-typeFatty Acids, Omega-3

Suppliers and Packaging for NDA: 204977

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMTRYG
omega-3-acid ethyl esters type a
CAPSULE;ORAL 204977 NDA Trygg Pharma Inc 61112-001 61112-001-01 120 CAPSULE in 1 BOTTLE (61112-001-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:Apr 23, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 23, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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