Application Sponsors
Marketing Status
Application Products
001 | GEL;TOPICAL | 1% | 0 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-01-27 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ENCUBE
cder:Array
(
[0] => Array
(
[ApplNo] => 210986
[companyName] => ENCUBE
[docInserts] => ["",""]
[products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/11\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-11
)
)