ANDA 211027

MYLAN

FDA Drug Application

Application #211027

Documents

• Letter: 2019-09-27

Application Sponsors

ANDA 211027

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.1%

0

HALCINONIDE

HALCINONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-12

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211027
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALCINONIDE","activeIngredients":"HALCINONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211027Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-12
        )

)