Orange Book product · Brand (NDA)
LOVAZA
OMEGA-3-ACID ETHYL ESTERS
At a glance
Nov 10, 2004
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 10, 2004
21 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
OMEGA-3-ACID ETHYL ESTERS
Strength
1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 021654
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2023OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 211345 · WILSHIRE PHARMS INC
- 2021OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 215458 · MANKIND PHARMA
- 2020OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 212504 · GLW
- 2020OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 210093 · PURACAP PHARM LLC
- 2020OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 211979 · CSPC-NBP PHARM
- 2020OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 210834 · SUN PHARM
- 2019OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 206455 · CHARTWELL
- 2019OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 211355 · SOFGEN PHARMS
- 2019OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 210107 · ZYDUS LIFESCIENCES
- 2019OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 207420 · ASCENT PHARMS INC
- 2017OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 203893 · ONESOURCE SPECIALTY
- 2015OMEGA-3-ACID ETHYL ESTERSGeneric (ANDA)
ANDA 204940 · AMNEAL PHARMS
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.
