Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021251
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KALETRA | LOPINAVIR; RITONAVIR | 80MG/ML;20MG/ML | SOLUTION;ORAL | Prescription | AA | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/15/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form and Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21251lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21251ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21251ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-226_Kaletra.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/21/2020 | SUPPL-59 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021906Orig1s054, 021251Orig1s059ltr.pdf | |
| 12/19/2019 | SUPPL-58 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s058,021906s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021906Orig1s053, 021251Orig1s058ltr.pdf | |
| 08/21/2019 | SUPPL-57 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s057,021906s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021906Orig1s052, 021251Orig1s057ltr.pdf | |
| 11/15/2018 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021251s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021251Orig1s056,021906Orig1s051ltr.pdf | |
| 10/13/2017 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/212906Orig1s050,021251Orig1s055ltr.pdf | |
| 06/15/2017 | SUPPL-54 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s054,021906s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021251Orig1s054,021906s049ltr.pdf | |
| 09/15/2016 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s053,021906s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021251Orig1s053,021906Orig1s047ltr.pdf | |
| 11/22/2016 | SUPPL-52 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s052_021906s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021251Orig1s052,021906Orig1s046ltr.pdf | |
| 11/10/2015 | SUPPL-51 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s051,021906s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s051,021906Orig1s044ltr.pdf | |
| 03/27/2015 | SUPPL-50 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s050,021906s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s050,021906Orig1s043ltr.pdf | |
| 06/26/2015 | SUPPL-49 | Efficacy-Pediatric, Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s042,021251Orig1s049ltr.pdf | |
| 01/28/2015 | SUPPL-47 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s047,021906s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s040,021251Orig1s047ltr.pdf | |
| 11/07/2013 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s039,021251Orig1s046ltr.pdf | |
| 01/17/2013 | SUPPL-45 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s045,021906s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s038,021251Orig1s045ltr.pdf | |
| 05/16/2012 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s036,021251s044ltr.pdf | |
| 02/17/2012 | SUPPL-42 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s042,021906s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021251s042,021906s035ltr.pdf | |
| 04/20/2012 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s034,021251s041ltr.pdf | |
| 05/06/2011 | SUPPL-40 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s040,21906s033ltr.pdf |
| 02/24/2011 | SUPPL-39 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021251s039,021906s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s039,021906s032ltr.pdf | |
| 06/14/2010 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s033,021906s026ltr.pdf | |
| 04/27/2010 | SUPPL-31 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s024,021251s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021906s024,021251s031ltr.pdf | |
| 01/29/2010 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s029,021906s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s029,021906s022ltr.pdf | |
| 04/20/2009 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s026,021906s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s017,021251s026ltr.pdf | |
| 10/03/2008 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021906s015,021251s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021906s015, 021251s024ltr.pdf | |
| 04/06/2009 | SUPPL-23 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s023,021906s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s014,021251s023ltr.pdf | |
| 06/20/2008 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021251s022,021906s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021251s022, 021906s013ltr.pdf | |
| 09/25/2007 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021906s008,021251s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021906s008, 021251s019ltr.pdf | |
| 11/09/2007 | SUPPL-18 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s018,021906s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s018, 021906s007ltr.pdf | |
| 07/30/2008 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021251s017ltr.pdf |
| 06/29/2007 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s016,021906s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s016,021906s00533ltr.pdf | |
| 03/02/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s014,021906s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s014, 021906s004ltr.pdf | |
| 12/21/2006 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021906s003,021251s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021906s003, 21251s013ltr.pdf | |
| 04/20/2007 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s012,021906s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s012, 021906s002_LTR.pdf | |
| 03/28/2005 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s017,021251s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021226s017,021251s011ltr.pdf | |
| 10/19/2004 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21226s014,21251s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21226s014,21251s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021251_S010_KALETRA.pdf | |
| 12/03/2003 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21226slr012,21251slr009_kaletra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21226slr012,21251slr009ltr.pdf | |
| 12/24/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/2002 | SUPPL-5 | Efficacy-Accelerated Approval |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226se7-006,21251se7-005_Kaletra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021251_S005_KALETRA.pdf | |
| 01/18/2002 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21226s3ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-251S003_Kaletra.cfm | |
| 01/18/2002 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 03/13/2001 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21251s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra.cfm | |
| 01/30/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/21/2020 | SUPPL-59 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf | |
| 10/21/2020 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf | |
| 12/19/2019 | SUPPL-58 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s058,021906s053lbl.pdf | |
| 12/19/2019 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s058,021906s053lbl.pdf | |
| 08/21/2019 | SUPPL-57 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s057,021906s052lbl.pdf | |
| 08/21/2019 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s057,021906s052lbl.pdf | |
| 11/15/2018 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021251s056lbl.pdf | |
| 10/13/2017 | SUPPL-55 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf | |
| 10/13/2017 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf | |
| 06/15/2017 | SUPPL-54 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s054,021906s049lbl.pdf | |
| 06/15/2017 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s054,021906s049lbl.pdf | |
| 11/22/2016 | SUPPL-52 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s052_021906s046lbl.pdf | |
| 11/22/2016 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s052_021906s046lbl.pdf | |
| 09/15/2016 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s053,021906s047lbl.pdf | |
| 11/10/2015 | SUPPL-51 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s051,021906s044lbl.pdf | |
| 11/10/2015 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s051,021906s044lbl.pdf | |
| 06/26/2015 | SUPPL-49 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf | |
| 06/26/2015 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf | |
| 06/26/2015 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf | |
| 06/26/2015 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf | |
| 03/27/2015 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s050,021906s043lbl.pdf | |
| 03/27/2015 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s050,021906s043lbl.pdf | |
| 01/28/2015 | SUPPL-47 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s047,021906s040lbl.pdf | |
| 11/07/2013 | SUPPL-46 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf | |
| 11/07/2013 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf | |
| 01/17/2013 | SUPPL-45 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s045,021906s038lbl.pdf | |
| 01/17/2013 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s045,021906s038lbl.pdf | |
| 05/16/2012 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044lbl.pdf | |
| 04/20/2012 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034lbl.pdf | |
| 02/17/2012 | SUPPL-42 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s042,021906s035lbl.pdf | |
| 02/24/2011 | SUPPL-39 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021251s039,021906s032lbl.pdf | |
| 06/14/2010 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s033lbl.pdf | |
| 04/27/2010 | SUPPL-31 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s024,021251s031lbl.pdf | |
| 01/29/2010 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s029,021906s022lbl.pdf | |
| 04/20/2009 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s026,021906s017lbl.pdf | |
| 04/06/2009 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s023,021906s014lbl.pdf | |
| 04/06/2009 | SUPPL-23 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s023,021906s014lbl.pdf | |
| 10/03/2008 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021906s015,021251s024lbl.pdf | |
| 06/20/2008 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021251s022,021906s013lbl.pdf | |
| 11/09/2007 | SUPPL-18 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s018,021906s007lbl.pdf | |
| 09/25/2007 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021906s008,021251s019lbl.pdf | |
| 06/29/2007 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s016,021906s005lbl.pdf | |
| 04/20/2007 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s012,021906s002lbl.pdf | |
| 03/02/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s014,021906s004lbl.pdf | |
| 12/21/2006 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021906s003,021251s013lbl.pdf | |
| 03/28/2005 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s017,021251s011lbl.pdf | |
| 10/19/2004 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21226s014,21251s010lbl.pdf | |
| 12/03/2003 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21226slr012,21251slr009_kaletra_lbl.pdf | |
| 11/27/2002 | SUPPL-5 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226se7-006,21251se7-005_Kaletra_lbl.pdf | |
| 01/18/2002 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226s3lbl.pdf | |
| 03/13/2001 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra_prntlbl.pdf | |
| 09/15/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21251lbl.pdf |
KALETRA
SOLUTION;ORAL; 80MG/ML;20MG/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KALETRA | LOPINAVIR; RITONAVIR | 80MG/ML;20MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 021251 | ABBVIE |
| LOPINAVIR AND RITONAVIR | LOPINAVIR; RITONAVIR | 80MG/ML;20MG/ML | SOLUTION;ORAL | Prescription | No | AA | 207407 | LANNETT CO INC |