AM REGENT FDA Approval ANDA 091104

ANDA 091104

AM REGENT

FDA Drug Application

Application #091104

Application Sponsors

ANDA 091104AM REGENT

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION1MG/10ML (0.1MG/ML)0CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE
002INJECTABLE;INJECTION5MG/10ML (0.5MG/ML)0CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2009-10-08
LABELING; LabelingSUPPL2AP2011-07-21

Submissions Property Types

ORIG1Null1
SUPPL2Null7

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91104
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"5MG\/10ML (0.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"1MG\/10ML (0.1MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"5MG\/10ML (0.5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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