ANDA 205988

MACLEODS PHARMS LTD

FDA Drug Application

Application #205988

Application Sponsors

ANDA 205988

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

10MG

0

VARDENAFIL HYDROCHLORIDE

VARDENAFIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205988
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-10
        )

)