ANDA 213847

MYLAN

FDA Drug Application

Application #213847

Application Sponsors

ANDA 213847

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

7.5%

0

DAPSONE

DAPSONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213847
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPSONE","activeIngredients":"DAPSONE","strength":"7.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-04
        )

)