Application Sponsors
Marketing Status
Application Products
001 | CAPSULE;ORAL | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | 0 | OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-01-09 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
SUN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 210834
[companyName] => SUN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"OMEGA-3-ACID ETHYL ESTERS","activeIngredients":"OMEGA-3-ACID ETHYL ESTERS","strength":"1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-01-09
)
)