ANDA 207290

MACLEODS PHARMS LTD

FDA Drug Application

Application #207290

Application Sponsors

ANDA 207290

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

20MG

0

TADALAFIL

TADALAFIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-10-16	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-02-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AB2

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207290
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-16
        )

)