ANDA 209148

TARO

FDA Drug Application

Application #209148

Documents

• Letter: 2018-11-15

Application Sponsors

ANDA 209148

TARO

Marketing Status

• Discontinued: 001

Application Products

001

GEL;TOPICAL

0.3%;2.5%

0

ADAPALENE AND BENZOYL PEROXIDE

ADAPALENE; BENZOYL PEROXIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209148
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADAPALENE AND BENZOYL PEROXIDE","activeIngredients":"ADAPALENE; BENZOYL PEROXIDE","strength":"0.3%;2.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209148Orig1s000Ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-17
        )

)