ANDA 210986

ENCUBE

FDA Drug Application

Application #210986

Application Sponsors

ANDA 210986

ENCUBE

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

1%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-01-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ENCUBE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210986
            [companyName] => ENCUBE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/11\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-11
        )

)