ANDA 208322

TARO

FDA Drug Application

Application #208322

Application Sponsors

ANDA 208322

TARO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.3%

0

ADAPALENE

ADAPALENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-06-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208322
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADAPALENE","activeIngredients":"ADAPALENE","strength":"0.3%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-23
        )

)