Application Sponsors
ANDA 206715 | RICONPHARMA LLC | |
Marketing Status
Application Products
001 | SOLUTION;TOPICAL | 1.5% | 0 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-08-07 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-04-30 | STANDARD |
Submissions Property Types
CDER Filings
RICONPHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 206715
[companyName] => RICONPHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1.5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-08-07
)
)