ANDA 207769

ZYDUS PHARMS

FDA Drug Application

Application #207769

Application Sponsors

ANDA 207769

ZYDUS 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

2018-05-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207769
            [companyName] => ZYDUS 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":"05\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-24
        )

)