Kaletra

Treats HIV-1 infection. NDA 21906, held by Abbvie. Lopinavir; Ritonavir.

As of Nov 15, 2026, NDA 21906 (Kaletra), held by Abbvie, was first approved by FDA on Oct 28, 2005, with 36 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2005
Review: Priority
Supplements approved: 36
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 submissions below


Jun 26, 2015	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 28, 2015	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 27, 2010	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 20, 2009	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 9, 2007	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Label Letter
Apr 20, 2007	Supplement 2Efficacy (new indication or use)	Approved	Label Letter
Oct 28, 2005	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

2 strengths and forms


Kaletra200MG;50MG · tablet;oral	Lopinavir; Ritonavir	RxReference drug
Kaletra100MG;25MG · tablet;oral	Lopinavir; Ritonavir	RxReference drug

All 37 submissions, including labeling and manufacturing supplements


Jul 23, 2026	Supplement 55Labeling · Standard review	Approved	Label Letter
Oct 21, 2020	Supplement 54Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 19, 2019	Supplement 53Labeling · Standard review	Approved	Letter Label Medication Guide
Aug 21, 2019	Supplement 52Labeling · Standard review	Approved	Letter Label
Nov 15, 2018	Supplement 51Labeling · Standard review	Approved	Letter Label
Oct 13, 2017	Supplement 50Labeling · Standard review	Approved	Label Medication Guide Letter
Jun 15, 2017	Supplement 49Labeling · Standard review	Approved	Label Letter
Nov 22, 2016	Supplement 46Labeling · Standard review	Approved	Label Letter
Sep 15, 2016	Supplement 47Labeling · Standard review	Approved	Letter Label
Dec 2, 2015	Supplement 45Manufacturing · Priority review	Approved	None posted
Nov 10, 2015	Supplement 44Labeling · Standard review	Approved	Letter Label
Jun 26, 2015	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 27, 2015	Supplement 43Labeling	Approved	Label Letter
Jan 28, 2015	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 7, 2013	Supplement 39Labeling · Standard review	Approved	Letter Label
Jan 17, 2013	Supplement 38Labeling · Standard review	Approved	Letter Label
Nov 30, 2012	Supplement 37Manufacturing · Priority review	Approved	None posted
May 16, 2012	Supplement 36Labeling · Standard review	Approved	Letter Label
Apr 20, 2012	Supplement 34Labeling · Standard review	Approved	Letter Label
Feb 17, 2012	Supplement 35Labeling	Approved	Letter Label
May 6, 2011	Supplement 33REMS	Approved	Letter
Feb 24, 2011	Supplement 32Labeling · Standard review	Approved	Label Letter
Jun 14, 2010	Supplement 26Labeling	Approved	Letter Label
Apr 27, 2010	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 29, 2010	Supplement 22Labeling · Standard review	Approved	Letter Label
Apr 20, 2009	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 6, 2009	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 3, 2008	Supplement 15Labeling · Standard review	Approved	Label Letter
Jun 20, 2008	Supplement 13Labeling · Standard review	Approved	Label Letter
Nov 9, 2007	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 25, 2007	Supplement 8Labeling · Standard review	Approved	Letter Label
Jun 29, 2007	Supplement 5Labeling · Standard review	Approved	Letter Label
Apr 20, 2007	Supplement 2Efficacy (new indication or use)	Approved	Label Letter
Mar 2, 2007	Supplement 4Labeling · Standard review	Approved	Label Letter
Dec 21, 2006	Supplement 3Labeling · Standard review	Approved	Letter Label
Jul 5, 2006	Supplement 1Manufacturing	Approved	None posted
Oct 28, 2005	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21906
Drugs@FDA: Overview at FDA
Company: AbbVie

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