ANDA 209909

HUMANWELL PURACAP

FDA Drug Application

Application #209909

Application Sponsors

ANDA 209909

HUMANWELL PURACAP

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.5MG

0

DUTASTERIDE

DUTASTERIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-05-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

HUMANWELL PURACAP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209909
            [companyName] => HUMANWELL PURACAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUTASTERIDE","activeIngredients":"DUTASTERIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/26\/2021","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-05-26
        )

)