SUN PHARM INDS LTD FDA Approval ANDA 090800

ANDA 090800

SUN PHARM INDS LTD

FDA Drug Application

Application #090800

Application Sponsors

ANDA 090800SUN PHARM INDS LTD

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET;ORALEQ 5MG BASE0QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDE
002TABLET;ORALEQ 10MG BASE0QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDE
003TABLET;ORALEQ 20MG BASE0QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDE
004TABLET;ORALEQ 40MG BASE0QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDE

FDA Submissions

ORIG1AP2009-06-18

Submissions Property Types

SUPPL1Null7

CDER Filings

SUN PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90800
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE","activeIngredients":"QUINAPRIL HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUINAPRIL HYDROCHLORIDE","submission":"QUINAPRIL HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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