PRINSTON INC FDA Approval ANDA 078110

ANDA 078110

PRINSTON INC

FDA Drug Application

Application #078110

Application Sponsors

ANDA 078110PRINSTON INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001TABLET;ORALEQ 0.25MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
002TABLET;ORALEQ 0.5MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
003TABLET;ORALEQ 1MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
004TABLET;ORALEQ 2MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
005TABLET;ORALEQ 3MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
006TABLET;ORALEQ 4MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
007TABLET;ORALEQ 5MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE

FDA Submissions

ORIG1AP2008-05-05
LABELING; LabelingSUPPL6AP2015-12-11
LABELING; LabelingSUPPL9AP2015-04-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2015-12-11UNKNOWN
LABELING; LabelingSUPPL12AP2020-02-21STANDARD
LABELING; LabelingSUPPL14AP2020-02-21STANDARD
LABELING; LabelingSUPPL17AP2020-02-21STANDARD

Submissions Property Types

SUPPL6Null7
SUPPL9Null7
SUPPL11Null15
SUPPL12Null7
SUPPL14Null15
SUPPL17Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
007PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78110
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 0.25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 3MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 0.25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 0.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 3MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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