Application Sponsors
| ANDA 203893 | STRIDES PHARMA | |
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 | 2017-09-19 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-03-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2020-10-02 | |
| LABELING; Labeling | SUPPL | 15 | AP | 2020-10-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 7 |
TE Codes
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 203893
[companyName] => STRIDES PHARMA
[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":"09\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/09\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-09
)
)