ANDA 212351

ALEOR DERMACEUTICALS

FDA Drug Application

Application #212351

Application Sponsors

ANDA 212351

ALEOR DERMACEUTICALS

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

3%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ALEOR DERMACEUTICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212351
            [companyName] => ALEOR DERMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"3%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-27
        )

)