FDA.reportPublic FDA data

Application 021251

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KALETRALOPINAVIR; RITONAVIRSOLUTION;ORAL80MG/ML;20MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-3956KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65010SUPPL2020-10-23
65009SUPPL2020-10-23
64989SUPPL2020-10-23
61431SUPPL2019-12-23
61430SUPPL2019-12-23
61396SUPPL2019-12-23
59817SUPPL2019-08-22
59809SUPPL2019-08-22
56688SUPPL2018-12-07
56537SUPPL2018-11-23
50082SUPPL2017-10-18
50079SUPPL2017-10-18
50075SUPPL2017-10-18
48745SUPPL2017-06-16
48734SUPPL2017-06-16
45967SUPPL2016-11-29
45945SUPPL2016-11-23
45331SUPPL2016-09-20
45322SUPPL2016-09-15
4774SUPPL2015-11-17
14750SUPPL2015-11-12
27219SUPPL2015-07-06
36466SUPPL2015-07-01
14749SUPPL2015-04-02
27220SUPPL2015-04-01
36465SUPPL2015-01-30
4773SUPPL2015-01-29
36464SUPPL2013-11-08
27218SUPPL2013-11-08
36463SUPPL2013-01-22
27217SUPPL2013-01-22
4772SUPPL2012-05-18
14748SUPPL2012-05-17
14746SUPPL2012-04-24
4771SUPPL2012-04-24
27216SUPPL2012-02-27
14747SUPPL2012-02-22
4770SUPPL2011-05-10
36462SUPPL2011-03-04
4769SUPPL2011-03-01
27215SUPPL2010-06-16
36461SUPPL2010-06-15
36460SUPPL2010-05-07
4768SUPPL2010-05-03
4767SUPPL2010-02-05
14745SUPPL2010-02-04
27214SUPPL2009-04-24
14744SUPPL2009-04-23
14742SUPPL2009-04-16
4766SUPPL2009-04-10
14743SUPPL2008-10-09
27213SUPPL2008-10-08
4763SUPPL2008-08-05
14741SUPPL2008-06-26
27212SUPPL2008-06-24
52942SUPPL2008-03-07
52941SUPPL2008-03-07
52322SUPPL2008-03-07
52321SUPPL2008-03-07
52320SUPPL2008-03-07
52319SUPPL2008-03-07
52318SUPPL2008-03-07
52317SUPPL2008-03-07
52316SUPPL2008-03-07
36459SUPPL2007-11-19
4764SUPPL2007-11-19
4765SUPPL2007-10-04
42055SUPPL2007-09-26
21549SUPPL2007-09-26
14740SUPPL2007-09-26
27211SUPPL2007-07-05
14739SUPPL2007-07-05
27208SUPPL2007-04-25
14737SUPPL2007-04-25
27210SUPPL2007-03-07
14738SUPPL2007-03-07
27209SUPPL2007-01-08
36458SUPPL2006-12-28
27207SUPPL2005-03-30
14736SUPPL2005-03-30
36457SUPPL2004-10-26
27206SUPPL2004-10-26
14735SUPPL2003-12-08
4762SUPPL2003-12-08
14734SUPPL2002-11-27
42054SUPPL2002-01-18
36456SUPPL2002-01-18
27205SUPPL2002-01-18
42053SUPPL2001-03-13
36455SUPPL2001-03-13
27204SUPPL2001-03-13
23070ORIG2000-09-15
21548ORIG2000-09-15
14733ORIG2000-09-15
4761ORIG2000-09-15