ANDA 200300

HIKMA FARMACEUTICA

FDA Drug Application

Application #200300

Application Sponsors

ANDA 200300

HIKMA FARMACEUTICA

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

N/A; Not Applicable

ORIG

1

AP

2011-01-26

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200300
            [companyName] => HIKMA FARMACEUTICA
            [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":"01\/26\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2011-01-26
        )

)