ANDA 212506

ALEOR DERMACEUTICALS

FDA Drug Application

Application #212506

Application Sponsors

ANDA 212506

ALEOR DERMACEUTICALS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;TOPICAL

2%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-11-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ALEOR DERMACEUTICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212506
            [companyName] => ALEOR DERMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/29\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-29
        )

)