Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION;TOPICAL | 2% | 0 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2015-10-14 | STANDARD |
Submissions Property Types
CDER Filings
PADDOCK LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 208068
[companyName] => PADDOCK LABS
[docInserts] => ["",""]
[products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/14\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/208068Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-10-14
)
)