AUROLIFE PHARMA LLC FDA Approval ANDA 070886

ANDA 070886

AUROLIFE PHARMA LLC

FDA Drug Application

Application #070886

Application Sponsors

ANDA 070886AUROLIFE PHARMA LLC

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORAL0.2MG0CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE
002TABLET;ORAL0.1MG0CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE
003TABLET;ORAL0.3MG0CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1988-08-31
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1992-03-04
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1995-02-01
LABELING; LabelingSUPPL5AP1998-03-25
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-03-02

Submissions Property Types

SUPPL3Null0
SUPPL4Null0
SUPPL6Null0

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70886
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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