ANDA 208108

GLENMARK PHARMS LTD

FDA Drug Application

Application #208108

Application Sponsors

ANDA 208108

GLENMARK PHARMS LTD

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

2019-11-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208108
            [companyName] => GLENMARK PHARMS LTD
            [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":"11\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-08
        )

)