CADILA FDA Approval ANDA 090411

ANDA 090411

CADILA

FDA Drug Application

Application #090411

Application Sponsors

ANDA 090411CADILA

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

ORIG1AP2009-06-01
LABELING; LabelingSUPPL2AP2013-08-30STANDARD
LABELING; LabelingSUPPL5AP2015-10-28STANDARD
LABELING; LabelingSUPPL6AP2020-04-07STANDARD

Submissions Property Types

SUPPL1Null15
SUPPL2Null8
SUPPL5Null15
SUPPL6Null7

TE Codes

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

CDER Filings

CADILA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90411
            [companyName] => CADILA
            [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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