ANDA 208198

AMNEAL PHARMS

FDA Drug Application

Application #208198

Application Sponsors

ANDA 208198

AMNEAL PHARMS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;TOPICAL

2%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-06-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208198
            [companyName] => AMNEAL PHARMS
            [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":"06\/09\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-09
        )

)