FDA.reportPublic FDA data

Application 020478

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ULTANESEVOFLURANELIQUID;INHALATION100%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent
0074-4456UltaneSevofluraneAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81154SUPPL 2025-02-07
81073SUPPL 2025-02-06
72543SUPPL2022-11-02
72532SUPPL2022-11-02
71111SUPPL2022-05-20
71108SUPPL2022-05-20
70369SUPPL2022-03-02
70368SUPPL2022-03-02
70367SUPPL2022-03-02
70366SUPPL2022-03-02
70352SUPPL2022-03-02
70351SUPPL2022-03-02
70350SUPPL2022-03-02
70349SUPPL2022-03-02
57649ORIG2019-02-15
48415SUPPL2017-05-17
48414SUPPL2017-05-17
48413SUPPL2017-05-17
48222SUPPL2017-05-02
34692SUPPL2014-03-13
25021SUPPL2014-03-13
12623SUPPL2014-03-13
2582SUPPL2014-03-13
25020SUPPL2012-08-17
12622SUPPL2012-08-17
12621SUPPL2012-08-17
2581SUPPL2012-08-17
25019SUPPL2010-01-28
34691SUPPL2010-01-24
41388SUPPL2007-05-30
20674SUPPL2007-05-29
25018SUPPL2006-07-03
34690SUPPL2006-06-28
34689SUPPL2005-06-23
2580SUPPL2005-06-23
25016SUPPL2004-06-29
25017SUPPL2003-07-06
12620SUPPL2001-03-30
2579SUPPL2001-03-30