ANDA 208247

STRIDES PHARMA

FDA Drug Application

Application #208247

Application Sponsors

ANDA 208247

STRIDES PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MCG

0

ROFLUMILAST

ROFLUMILAST

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-30

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208247
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROFLUMILAST","activeIngredients":"ROFLUMILAST","strength":"500MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-30
        )

)