GLAXOSMITHKLINE LLC FDA Approval NDA 020658

NDA 020658

GLAXOSMITHKLINE LLC

FDA Drug Application

Application #020658

Documents

Letter2003-06-22
Letter2009-01-06
Letter2014-09-02
Letter2014-09-02
Letter2014-09-02
Letter2014-09-02
Label2005-05-17
Label2009-01-06
Label2014-09-02
Review2006-05-16
Letter2005-05-17
Letter2009-01-06
Letter2009-01-06
Letter2014-09-02
Letter2012-03-23
Label2009-01-06
Label2009-01-06
Label2014-09-02
Label2014-09-02
Label2014-09-02
Label2014-09-02
Review2007-07-17
Review2016-02-03
Other Important Information from FDA2011-12-20
Letter2016-09-15
Label2017-01-24
Letter2017-05-09
Label2017-05-09
Letter2020-04-06
Label2020-04-09
Letter2021-07-14
Label2021-07-15

Application Sponsors

NDA 020658GLAXOSMITHKLINE LLC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001TABLET;ORALEQ 0.25MG BASE1REQUIPROPINIROLE HYDROCHLORIDE
002TABLET;ORALEQ 0.5MG BASE1REQUIPROPINIROLE HYDROCHLORIDE
003TABLET;ORALEQ 1MG BASE1REQUIPROPINIROLE HYDROCHLORIDE
004TABLET;ORALEQ 2MG BASE1REQUIPROPINIROLE HYDROCHLORIDE
005TABLET;ORALEQ 5MG BASE1REQUIPROPINIROLE HYDROCHLORIDE
006TABLET;ORALEQ 3MG BASE1REQUIPROPINIROLE HYDROCHLORIDE
007TABLET;ORALEQ 4MG BASE1REQUIPROPINIROLE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1997-09-19STANDARD
LABELING; LabelingSUPPL3AP2000-05-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-08-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-11-02STANDARD
LABELING; LabelingSUPPL7AP2000-05-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2001-03-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2001-04-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2001-07-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2002-10-22STANDARD
LABELING; LabelingSUPPL12AP2003-06-19STANDARD
EFFICACY; EfficacySUPPL13AP2005-05-04PRIORITY
LABELING; LabelingSUPPL18AP2008-12-31STANDARD
LABELING; LabelingSUPPL20AP2008-12-31STANDARD
LABELING; LabelingSUPPL21AP2008-12-31STANDARD
LABELING; LabelingSUPPL24AP2014-08-28STANDARD
LABELING; LabelingSUPPL26AP2014-08-28STANDARD
LABELING; LabelingSUPPL27AP2014-08-28STANDARD
LABELING; LabelingSUPPL30AP2014-08-28UNKNOWN
LABELING; LabelingSUPPL31AP2012-03-19STANDARD
LABELING; LabelingSUPPL32AP2014-08-28STANDARD
LABELING; LabelingSUPPL33AP2016-09-09STANDARD
LABELING; LabelingSUPPL34AP2017-05-05STANDARD
LABELING; LabelingSUPPL37AP2020-04-03901 REQUIRED
LABELING; LabelingSUPPL38AP2021-07-12STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL24Null6
SUPPL26Null6
SUPPL27Null6
SUPPL30Null7
SUPPL31Null15
SUPPL32Null6
SUPPL33Null6
SUPPL34Null7
SUPPL37Null15
SUPPL38Null6

TE Codes

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

CDER Filings

GLAXOSMITHKLINE LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20658
            [companyName] => GLAXOSMITHKLINE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REQUIP","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 0.25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"REQUIP","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REQUIP","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REQUIP","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REQUIP","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REQUIP","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 3MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REQUIP","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/03\/2020","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020658Orig1s037lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2017","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020658s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2016","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020658s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020658s024s026s027s030s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020658s024s026s027s030s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020658s024s026s027s030s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020658s024s026s027s030s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020658s024s026s027s030s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2008","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020658s018s020s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2008","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020658s018s020s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2008","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020658s018s020s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2005","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020658s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"REQUIP","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 0.25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 0.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 3MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REQUIP","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-03
        )

)
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