ANDA 208180

MICRO LABS

FDA Drug Application

Application #208180

Documents

• Letter: 2018-12-06

Application Sponsors

ANDA 208180

MICRO LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MCG

0

ROFLUMILAST

ROFLUMILAST

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208180
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROFLUMILAST","activeIngredients":"ROFLUMILAST","strength":"500MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208180Orig1s000TALtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-22
        )

)