OMEGA-3-ACID ETHYL ESTERS | A091018 | ONESOURCE SPECIALTY PTE LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Crowell & Moring LLP - Citizen Petition FDA-2013-P-0148 · 4 docket documents Crowell & Moring LLP filed this citizen petition on behalf of an unnamed petitioner requesting that the FDA Commissioner amend the adopted strength for Lovaza (omega-3-acid ethyl esters) Capsules, currently listed in the Orange Book as "1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATT | Other | 2013-03-01 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.