ABBVIE FDA Approval NDA 020478

NDA 020478

ABBVIE

FDA Drug Application

Application #020478

Documents

Letter2001-03-30
Letter2005-06-23
Letter2012-08-17
Letter2014-03-13
Label2001-03-30
Label2012-08-17
Label2012-08-17
Label2014-03-13
Review2007-05-29
Letter2004-06-29
Letter2003-07-06
Letter2006-07-03
Letter2010-01-28
Letter2012-08-17
Letter2014-03-13
Label2005-06-23
Label2006-06-28
Label2010-01-24
Label2014-03-13
Review2007-05-30
Label2017-05-02
Review2017-05-17
Label2017-05-17
Review2017-05-17
Review2019-02-15
Letter2022-03-02
Letter2022-03-02
Letter2022-03-02
Letter2022-03-02
Label2022-03-02
Label2022-03-02
Label2022-03-02
Label2022-03-02
Label2022-05-20
Letter2022-05-20
Letter2022-11-02
Label2022-11-02

Application Sponsors

NDA 020478ABBVIE

Marketing Status

Prescription001

Application Products

001LIQUID;INHALATION100%1ULTANESEVOFLURANE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1995-06-07STANDARD
LABELING; LabelingSUPPL2AP1997-12-23STANDARD
LABELING; LabelingSUPPL3AP1998-08-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-06-16STANDARD
EFFICACY; EfficacySUPPL6AP2001-03-30STANDARD
LABELING; LabelingSUPPL7AP2002-12-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2001-03-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2001-09-28STANDARD
LABELING; LabelingSUPPL10AP2001-08-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2002-05-24STANDARD
LABELING; LabelingSUPPL12AP2003-06-27STANDARD
LABELING; LabelingSUPPL13AP2005-06-21STANDARD
LABELING; LabelingSUPPL16AP2006-06-27STANDARD
LABELING; LabelingSUPPL18AP2010-01-21STANDARD
LABELING; LabelingSUPPL19AP2012-08-16STANDARD
LABELING; LabelingSUPPL20AP2012-08-16STANDARD
LABELING; LabelingSUPPL23AP2022-03-01STANDARD
LABELING; LabelingSUPPL24AP2022-03-01STANDARD
LABELING; LabelingSUPPL25AP2014-03-11STANDARD
LABELING; LabelingSUPPL26AP2014-03-11STANDARD
LABELING; LabelingSUPPL27AP2022-03-01STANDARD
LABELING; LabelingSUPPL28AP2022-03-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2015-10-26STANDARD
LABELING; LabelingSUPPL30AP2017-04-27STANDARD
LABELING; LabelingSUPPL32AP2022-05-19STANDARD
LABELING; LabelingSUPPL34AP2022-11-01STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL6Null26
SUPPL8Null0
SUPPL9Null0
SUPPL11Null0
SUPPL18Null6
SUPPL19Null6
SUPPL20Null6
SUPPL23Null7
SUPPL24Null15
SUPPL25Null15
SUPPL26Null6
SUPPL27Null7
SUPPL28Null7
SUPPL29Null0
SUPPL30Null15
SUPPL32Null15
SUPPL34Null15

TE Codes

001PrescriptionAN

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20478
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTANE","activeIngredients":"SEVOFLURANE","strength":"100%","dosageForm":"LIQUID;INHALATION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/27\/2017","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020478s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2015","submission":"SUPPL-29","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020478Orig1S029.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/11\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020478s025s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2014","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020478s025s026lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020478s019s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020478s019s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/21\/2010","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020478s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2006","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020478s016lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2005","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020478s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2001","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20478S6LBL.PDF\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ULTANE","submission":"SEVOFLURANE","actionType":"100%","submissionClassification":"LIQUID;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-04-27
        )

)
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