ANDA 206493

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #206493

Documents

• Letter: 2015-12-07

Application Sponsors

ANDA 206493

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

3%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-12-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206493
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"3%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206493Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-02
        )

)