COREPHARMA FDA Approval ANDA 076102

ANDA 076102

COREPHARMA

FDA Drug Application

Application #076102

Application Sponsors

ANDA 076102COREPHARMA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;ORAL2.5MG0LISINOPRILLISINOPRIL
002TABLET;ORAL5MG0LISINOPRILLISINOPRIL
003TABLET;ORAL10MG0LISINOPRILLISINOPRIL
004TABLET;ORAL20MG0LISINOPRILLISINOPRIL
005TABLET;ORAL30MG0LISINOPRILLISINOPRIL
006TABLET;ORAL40MG0LISINOPRILLISINOPRIL

FDA Submissions

ORIG1AP2002-09-30
LABELING; LabelingSUPPL5AP2006-06-08
LABELING; LabelingSUPPL6AP2008-08-22
LABELING; LabelingSUPPL10AP2013-08-16STANDARD
LABELING; LabelingSUPPL11AP2016-07-13STANDARD
LABELING; LabelingSUPPL12AP2016-07-13STANDARD
LABELING; LabelingSUPPL13AP2016-07-13STANDARD
LABELING; LabelingSUPPL14AP2016-07-13STANDARD
LABELING; LabelingSUPPL15AP2016-07-13STANDARD
LABELING; LabelingSUPPL16AP2020-04-29STANDARD

Submissions Property Types

SUPPL10Null15
SUPPL11Null15
SUPPL12Null15
SUPPL13Null7
SUPPL14Null7
SUPPL15Null7
SUPPL16Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

COREPHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76102
            [companyName] => COREPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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