ANDA 208236

BRECKENRIDGE

FDA Drug Application

Application #208236

Application Sponsors

ANDA 208236

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MCG

0

ROFLUMILAST

ROFLUMILAST

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208236
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROFLUMILAST","activeIngredients":"ROFLUMILAST","strength":"500MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/03\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-03
        )

)