FDA.reportPublic FDA data

Application 021906

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KALETRALOPINAVIR; RITONAVIRTABLET;ORAL200MG;50MGYesYes
002KALETRALOPINAVIR; RITONAVIRTABLET;ORAL100MG;25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-0522KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-1575KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-1575KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-1575KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-1575KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-1575KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-2605KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-2605KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-2605KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-2605KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-2605KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
0074-6799KaletraLopinavir and RitonavirAbbVie Inc.NDACurrent
11819-342KaletraLopinavir and RitonavirHHS/Program Support Center/Supply Service CenterNDACurrent
21695-362Kaletralopinavir and ritonavirRebel Distributors CorpNDACurrent
53808-0276Kaletralopinavir and ritonavirDOH CENTRAL PHARMACYNDACurrent
55289-947KaletraLopinavir and RitonavirPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-947KaletraLopinavir and RitonavirPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-947KaletraLopinavir and RitonavirPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-947KaletraLopinavir and RitonavirPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-947KaletraLopinavir and RitonavirPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-947KaletraLopinavir and RitonavirPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-947KaletraLopinavir and RitonavirPD-Rx Pharmaceuticals, InNDACurrent
66336-624KaletraLopinavir and RitonavirDispensing Solutions, Inc.NDACurrent
68071-2348KaletraLopinavir and RitonavirNuCare Pharmaceuticals,Inc.NDACurrent
68258-1972KaletraLopinavir and RitonavirDispensing Solutions, Inc.NDACurrent
70518-0091KaletraLopinavir and RitonavirREMEDYREPACK INC.NDACurrent
70518-0091KaletraLopinavir and RitonavirREMEDYREPACK INC.NDACurrent
70518-0091KaletraLopinavir and RitonavirREMEDYREPACK INC.NDACurrent
70518-0091KaletraLopinavir and RitonavirREMEDYREPACK INC.NDACurrent
70518-0091KaletraLopinavir and RitonavirREMEDYREPACK INC.NDACurrent
70518-0091KaletraLopinavir and RitonavirREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65012SUPPL2020-10-23
65011SUPPL2020-10-23
64988SUPPL2020-10-23
61433SUPPL2019-12-23
61432SUPPL2019-12-23
61395SUPPL2019-12-23
59818SUPPL2019-08-22
59808SUPPL2019-08-22
56689SUPPL2018-12-07
56538SUPPL2018-11-23
50083SUPPL2017-10-18
50077SUPPL2017-10-18
50076SUPPL2017-10-18
48744SUPPL2017-06-16
48732SUPPL2017-06-16
45968SUPPL2016-11-29
45946SUPPL2016-11-23
45332SUPPL2016-09-20
45321SUPPL2016-09-16
6432SUPPL2015-11-17
16554SUPPL2015-11-12
28821SUPPL2015-07-06
37862SUPPL2015-07-01
16553SUPPL2015-04-02
28822SUPPL2015-04-01
37861SUPPL2015-01-30
6431SUPPL2015-01-29
37860SUPPL2013-11-08
28820SUPPL2013-11-08
37859SUPPL2013-01-22
28819SUPPL2013-01-22
28818SUPPL2012-05-18
37858SUPPL2012-05-17
16551SUPPL2012-04-24
6430SUPPL2012-04-24
28817SUPPL2012-02-27
16552SUPPL2012-02-22
6429SUPPL2011-05-10
37857SUPPL2011-03-04
6428SUPPL2011-03-01
28816SUPPL2010-06-16
37856SUPPL2010-06-15
37855SUPPL2010-05-07
6427SUPPL2010-05-03
6426SUPPL2010-02-05
16550SUPPL2010-02-04
6425SUPPL2009-04-24
16549SUPPL2009-04-23
16548SUPPL2009-04-16
6424SUPPL2009-04-10
37854SUPPL2008-10-09
28815SUPPL2008-10-08
37853SUPPL2008-06-26
28814SUPPL2008-06-24
28812SUPPL2007-11-19
16547SUPPL2007-11-19
28813SUPPL2007-10-04
37852SUPPL2007-09-26
42343ORIG2007-07-18
37851SUPPL2007-07-05
6423SUPPL2007-07-05
28809SUPPL2007-04-25
16545SUPPL2007-04-25
28811SUPPL2007-03-07
16546SUPPL2007-03-07
28810SUPPL2007-01-08
37850SUPPL2006-12-28
37849ORIG2005-11-01
6422ORIG2005-11-01