BOEHRINGER INGELHEIM FDA Approval NDA 020933

NDA 020933

BOEHRINGER INGELHEIM

FDA Drug Application

Application #020933

Documents

Letter2004-06-30
Letter2004-06-30
Letter2002-03-27
Letter2005-03-02
Letter2007-04-20
Letter2008-06-30
Letter2007-08-17
Letter2010-01-26
Letter2010-07-23
Letter2011-03-31
Label2004-06-30
Label2003-04-04
Label2003-08-06
Label2003-12-29
Label2007-04-20
Label2008-06-26
Label2007-08-17
Label2010-01-20
Label2011-03-28
Label2011-11-10
Label2012-11-15
Review2007-07-27
Letter2004-06-30
Letter2003-12-23
Letter2011-01-14
Letter2011-05-10
Letter2011-11-14
Letter2012-11-13
Letter2014-01-28
Label2005-03-02
Label2010-07-22
Label2011-01-10
Label2014-01-28
Review2004-02-09
Review2005-04-27
Label2017-03-28
Letter2017-03-29
Label2018-09-25
Medication Guide2018-09-25
Letter2018-10-01
Letter2022-06-13
Label2022-06-15
Medication Guide2022-06-15

Application Sponsors

NDA 020933BOEHRINGER INGELHEIM

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL50MG/5ML1VIRAMUNENEVIRAPINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1998-09-11PRIORITY
LABELING; LabelingSUPPL2AP2000-08-10STANDARD
LABELING; LabelingSUPPL3AP2000-11-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2001-05-17
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2001-02-23
LABELING; LabelingSUPPL6AP2002-12-31STANDARD
EFFICACY; EfficacySUPPL7AP2002-03-27UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2002-12-20
LABELING; LabelingSUPPL10AP2003-07-29STANDARD
LABELING; LabelingSUPPL11AP2003-12-22STANDARD
LABELING; LabelingSUPPL12AP2004-05-24STANDARD
LABELING; LabelingSUPPL14AP2005-02-24STANDARD
LABELING; LabelingSUPPL15AP2007-04-13STANDARD
EFFICACY; EfficacySUPPL17AP2008-06-24PRIORITY
LABELING; LabelingSUPPL19AP2007-08-16STANDARD
LABELING; LabelingSUPPL22AP2010-01-13STANDARD
LABELING; LabelingSUPPL26AP2010-07-20STANDARD
REMS; REMSSUPPL27AP2011-01-07N/A
LABELING; LabelingSUPPL28AP2011-03-25STANDARD
REMS; REMSSUPPL29AP2011-05-06N/A
LABELING; LabelingSUPPL30AP2011-11-09STANDARD
LABELING; LabelingSUPPL33AP2012-11-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL34AP2013-02-08
LABELING; LabelingSUPPL35AP2014-01-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2015-02-03
LABELING; LabelingSUPPL38AP2017-03-27STANDARD
LABELING; LabelingSUPPL40AP2018-09-24STANDARD
LABELING; LabelingSUPPL43AP2022-06-10STANDARD

Submissions Property Types

ORIG1Null41
SUPPL4Null0
SUPPL5Null0
SUPPL9Null0
SUPPL11Null9
SUPPL22Null7
SUPPL26Null31
SUPPL27Null6
SUPPL28Null6
SUPPL29Null6
SUPPL30Null6
SUPPL33Null7
SUPPL34Null0
SUPPL35Null6
SUPPL37Null0
SUPPL38Null15
SUPPL40Null15
SUPPL43Null7

TE Codes

001PrescriptionAA

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20933
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/020636s050,020933s040lbl.pdf#page=19"]
            [products] => [{"drugName":"VIRAMUNE","activeIngredients":"NEVIRAPINE","strength":"50MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/24\/2018","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020636s050,020933s040lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020636s048,020933s038lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2014","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020636s044,020933s035lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2012","submission":"SUPPL-33","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020636s042,020933s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2011","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020636s039_020933s030lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2011","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020933s028,020636s037lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2011","submission":"SUPPL-28","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020636s035,020933s026lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2010","submission":"SUPPL-26","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020636s035,020933s026lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2010","submission":"SUPPL-22","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020933s022,020636s032lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2010","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020636s026,020933s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2005","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/20636s025,20933s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2003","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20636slr021,20933slr011_viramune_lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2003","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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            [originalApprovals] => [{"actionDate":"VIRAMUNE","submission":"NEVIRAPINE","actionType":"50MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-09-24
        )

)
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