ANDA 203786

VERSAPHARM INC

FDA Drug Application

Application #203786

Application Sponsors

ANDA 203786

VERSAPHARM INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;TOPICAL

1.5% W/W

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-10-28

Submissions Property Types

ORIG

1

Null

19

CDER Filings

VERSAPHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203786
            [companyName] => VERSAPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1.5% W\/W","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-28
        )

)