ANDA 206959

TARO

FDA Drug Application

Application #206959

Documents

• Letter: 2017-06-06
• Letter: 2018-02-08

Application Sponsors

ANDA 206959

TARO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.1%;2.5%

0

ADAPALENE AND BENZOYL PEROXIDE

ADAPALENE; BENZOYL PEROXIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-01-24	STANDARD
LABELING; Labeling	ORIG	2	AP	2018-01-24	STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206959
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADAPALENE AND BENZOYL PEROXIDE","activeIngredients":"ADAPALENE; BENZOYL PEROXIDE","strength":"0.1%;2.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/24\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Labeling","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206959Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206959Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-01-24
        )

)