PRINSTON INC FDA Approval ANDA 076164

ANDA 076164

PRINSTON INC

FDA Drug Application

Application #076164

Documents

Letter2003-04-11

Application Sponsors

ANDA 076164PRINSTON INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

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

FDA Submissions

ORIG1AP2002-07-01
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2014-10-31
LABELING; LabelingSUPPL12AP2014-12-19STANDARD
LABELING; LabelingSUPPL13AP2016-02-02STANDARD
LABELING; LabelingSUPPL14AP2016-02-02STANDARD
LABELING; LabelingSUPPL15AP2020-05-28STANDARD
LABELING; LabelingSUPPL19AP2019-09-26STANDARD

Submissions Property Types

SUPPL11Null0
SUPPL12Null15
SUPPL13Null15
SUPPL14Null15
SUPPL15Null7
SUPPL19Null15

TE Codes

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

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76164
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"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":"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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