Orange Book product · Brand (NDA)
OMTRYG
OMEGA-3-ACID ETHYL ESTERS TYPE A
At a glance
Apr 23, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 23, 2014
12 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
OMEGA-3-ACID ETHYL ESTERS TYPE A
Strength
1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 204977
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
