Treats HIV-1 infection. NDA 21251, held by Abbvie. Lopinavir; Ritonavir.
As of Nov 14, 2026, NDA 21251 (Kaletra), held by Abbvie, was first approved by FDA on Sep 15, 2000, with 43 approved supplements and 0 published complete response letters.
KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA.
| Jun 26, 2015 | Supplement 49Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2015 | Supplement 47Efficacy (new indication or use) · Standard review | Approved | |
| Apr 27, 2010 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Apr 20, 2009 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Jun 20, 2008 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Nov 9, 2007 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Apr 20, 2007 | Supplement 12Efficacy (new indication or use) | Approved | |
| Oct 19, 2004 | Supplement 10Efficacy (new indication or use) | Approved | |
| Nov 27, 2002 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2002 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2002 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 15, 2000 | Original applicationTYPE 3/4 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kaletra80MG/ML;20MG/ML · solution;oral | Lopinavir; Ritonavir | RxReference drug |
| Jul 23, 2026 | Supplement 60Labeling · Standard review | Approved | |
| Oct 21, 2020 | Supplement 59Labeling · Standard review | Approved | |
| Dec 19, 2019 | Supplement 58Labeling · Standard review | Approved | |
| Aug 21, 2019 | Supplement 57Labeling · Standard review | Approved | |
| Nov 15, 2018 | Supplement 56Labeling · Standard review | Approved | |
| Oct 13, 2017 | Supplement 55Labeling · Standard review | Approved | |
| Jun 15, 2017 | Supplement 54Labeling · Standard review | Approved | |
| Nov 22, 2016 | Supplement 52Labeling · Standard review | Approved | |
| Sep 15, 2016 | Supplement 53Labeling | Approved | |
| Nov 10, 2015 | Supplement 51Labeling · Standard review | Approved | |
| Jun 26, 2015 | Supplement 49Efficacy (new indication or use) · Standard review | Approved | |
| Mar 27, 2015 | Supplement 50Labeling | Approved | |
| Jan 28, 2015 | Supplement 47Efficacy (new indication or use) · Standard review | Approved | |
| Nov 7, 2013 | Supplement 46Labeling · Standard review | Approved | |
| Jan 17, 2013 | Supplement 45Labeling · Standard review | Approved | |
| May 16, 2012 | Supplement 44Labeling · Standard review | Approved | |
| Apr 20, 2012 | Supplement 41Labeling · Standard review | Approved | |
| Feb 17, 2012 | Supplement 42Labeling | Approved | |
| May 6, 2011 | Supplement 40REMS | Approved | |
| Feb 24, 2011 | Supplement 39Labeling · Standard review | Approved | |
| Jun 14, 2010 | Supplement 33Labeling | Approved | |
| Apr 27, 2010 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Jan 29, 2010 | Supplement 29Labeling · Standard review | Approved | |
| Apr 20, 2009 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Apr 6, 2009 | Supplement 23Labeling · Standard review | Approved | |
| Oct 3, 2008 | Supplement 24Labeling · Standard review | Approved | |
| Jul 30, 2008 | Supplement 17Labeling · Standard review | Approved | |
| Jun 20, 2008 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Nov 9, 2007 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Sep 25, 2007 | Supplement 19Labeling · Standard review | Approved | |
| Jun 29, 2007 | Supplement 16Labeling · Standard review | Approved | |
| Apr 20, 2007 | Supplement 12Efficacy (new indication or use) | Approved | |
| Mar 2, 2007 | Supplement 14Labeling · Standard review | Approved | |
| Dec 21, 2006 | Supplement 13Labeling · Standard review | Approved | |
| Mar 28, 2005 | Supplement 11Labeling · Standard review | Approved | |
| Oct 19, 2004 | Supplement 10Efficacy (new indication or use) | Approved | |
| Dec 3, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Dec 24, 2002 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Nov 27, 2002 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2002 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2002 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 13, 2001 | Supplement 2Labeling · Standard review | Approved | |
| Jan 30, 2001 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 15, 2000 | Original applicationTYPE 3/4 · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
