ANDA 203167

XGEN PHARMS

FDA Drug Application

Application #203167

Application Sponsors

ANDA 203167

XGEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	1MG/10ML (0.1MG/ML)	0	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	5MG/10ML (0.5MG/ML)	0	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2013-10-29

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203167
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"5MG\/10ML (0.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-10-29
        )

)