ANDA 202010

ANCHEN PHARMS

FDA Drug Application

Application #202010

Application Sponsors

ANDA 202010

ANCHEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.4MG

0

TAMSULOSIN HYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-01-04
LABELING; Labeling	SUPPL	2	AP	2015-11-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-11-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202010
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAMSULOSIN HYDROCHLORIDE","activeIngredients":"TAMSULOSIN HYDROCHLORIDE","strength":"0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/04\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/16\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/16\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-11-16
        )

)