ANDA 202509

ANCHEN PHARMS

FDA Drug Application

Application #202509

Documents

• Letter: 2014-02-27

Application Sponsors

ANDA 202509

ANCHEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.5MG;0.4MG

0

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-02-26
LABELING; Labeling	SUPPL	11	AP	2020-10-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	11	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202509
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE","activeIngredients":"DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE","strength":"0.5MG;0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/26\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202509Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/23\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-23
        )

)