ROCHE FDA Approval NDA 021511

NDA 021511

ROCHE

FDA Drug Application

Application #021511

Documents

Letter2004-05-07
Letter2005-08-24
Letter2005-06-23
Letter2007-07-05
Letter2009-05-07
Letter2010-06-15
Letter2015-08-12
Label2002-12-03
Label2004-05-07
Label2005-03-03
Label2005-08-24
Label2010-10-12
Label2011-08-11
Review2004-08-10
Other2005-11-01
Other2005-09-22
Letter2002-12-03
Letter2005-03-03
Letter2005-08-19
Letter2005-11-30
Letter2008-04-22
Letter2009-05-07
Letter2010-03-08
Letter2010-10-13
Letter2010-12-22
Letter2011-08-11
Letter2011-08-26
Letter2011-05-11
Letter2013-02-08
Label2005-08-19
Label2005-11-30
Label2007-06-27
Label2010-03-05
Label2010-06-24
Label2010-12-22
Label2011-08-24
Label2013-02-08
Label2015-08-12
Medication Guide2016-12-09
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01

Application Sponsors

NDA 021511ROCHE

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**0COPEGUSRIBAVIRIN
002TABLET;ORAL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**0COPEGUSRIBAVIRIN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2002-12-03PRIORITY
LABELING; LabelingSUPPL2AP2004-05-05STANDARD
EFFICACY; EfficacySUPPL5AP2005-02-25PRIORITY
LABELING; LabelingSUPPL6AP2005-08-22STANDARD
LABELING; LabelingSUPPL7AP2005-08-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2005-06-21PRIORITY
LABELING; LabelingSUPPL12AP2005-11-23STANDARD
LABELING; LabelingSUPPL14AP2007-06-19STANDARD
LABELING; LabelingSUPPL15AP2008-04-17STANDARD
LABELING; LabelingSUPPL16AP2009-04-15STANDARD
LABELING; LabelingSUPPL17AP2009-04-15STANDARD
LABELING; LabelingSUPPL18AP2010-03-03STANDARD
LABELING; LabelingSUPPL19AP2010-06-09STANDARD
LABELING; LabelingSUPPL20AP2010-10-08STANDARD
EFFICACY; EfficacySUPPL21AP2010-12-21STANDARD
EFFICACY; EfficacySUPPL22AP2011-08-09STANDARD
EFFICACY; EfficacySUPPL23AP2011-08-22PRIORITY
REMS; REMSSUPPL24AP2011-05-09N/A
LABELING; LabelingSUPPL26AP2013-02-06901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2014-03-04PRIORITY
LABELING; LabelingSUPPL29AP2015-08-11STANDARD

Submissions Property Types

SUPPL8Null0
SUPPL18Null6
SUPPL19Null6
SUPPL20Null6
SUPPL21Null6
SUPPL22Null6
SUPPL23Null7
SUPPL24Null7
SUPPL26Null7
SUPPL27Null0
SUPPL29Null7

CDER Filings

ROCHE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21511
            [companyName] => ROCHE
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2015\/021511s029lbl.pdf#page=27"]
            [products] => [{"drugName":"COPEGUS","activeIngredients":"RIBAVIRIN","strength":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COPEGUS","activeIngredients":"RIBAVIRIN","strength":"400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/11\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021511s029lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2013","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021511s026lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2011","submission":"SUPPL-23","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021511s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2011","submission":"SUPPL-23","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021511s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2011","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021511s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2010","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2010","submission":"SUPPL-20","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s020lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2010","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2010","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2010","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021511s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2007","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021511s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2005","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021511s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2005","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021511s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2005","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021511s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2005","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021511s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2004","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21511slr002_copegus_lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21511_Copegus_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COPEGUS","submission":"RIBAVIRIN","actionType":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COPEGUS","submission":"RIBAVIRIN","actionType":"400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2015-08-11
        )

)

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