Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021226
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KALETRA | LOPINAVIR; RITONAVIR | 133.3MG;33.3MG | CAPSULE;ORAL | Discontinued | None | No | No |
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 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21226lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21226ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21226ppi.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-49 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021226s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021226Orig1s049ltr.pdf | |
| 12/19/2019 | SUPPL-48 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021226Orig1s048ltr.pdf | |
| 08/21/2019 | SUPPL-47 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021226Orig1s047ltr.pdf | |
| 11/15/2018 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021226s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021226Orig1s046tr.pdf | |
| 06/15/2017 | SUPPL-45 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021226s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021226Orig1s045ltr.pdf | |
| 09/15/2016 | SUPPL-44 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021226Orig1s044ltr.pdf | |
| 11/22/2016 | SUPPL-43 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021226Orig1s043ltr.pdf | |
| 11/10/2015 | SUPPL-42 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021226Orig1s042ltr.pdf | |
| 03/27/2015 | SUPPL-41 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021226Orig1s041ltr.pdf | |
| 06/26/2015 | SUPPL-40 | Labeling-Package Insert, Efficacy-Pediatric, Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021226Orig1s040ltr.pdf | |
| 11/07/2013 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021226Orig1s038ltr.pdf | |
| 01/17/2013 | SUPPL-37 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021226Orig1s037ltr.pdf | |
| 06/27/2012 | SUPPL-36 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021226s036ltr.pdf | |
| 02/17/2012 | SUPPL-35 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021226s035ltr.pdf | |
| 04/27/2010 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021226s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021226s030ltr.pdf | |
| 09/26/2007 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021226s022ltr.pdf | |
| 07/09/2007 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021226s020ltr.pdf | |
| 12/21/2006 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021226s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021226s019ltr.pdf | |
| 04/20/2007 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021226s018_LTR.pdf | |
| 03/28/2005 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021226_S017_KALETRA.pdf | |
| 04/29/2005 | SUPPL-16 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021226s016ltr.pdf | |
| 10/19/2004 | SUPPL-14 | 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/2004/021226_S014_KALETRA.pdf | |
| 12/03/2003 | SUPPL-12 | 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-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/2002 | SUPPL-6 | 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/2002/021226_S006_KALETRA.pdf | |
| 02/13/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-3 | 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 | |
| 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-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021226s049lbl.pdf | |
| 10/21/2020 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021226s049lbl.pdf | |
| 12/19/2019 | SUPPL-48 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s048lbl.pdf | |
| 12/19/2019 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s048lbl.pdf | |
| 08/21/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s047lbl.pdf | |
| 08/21/2019 | SUPPL-47 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s047lbl.pdf | |
| 11/15/2018 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021226s046lbl.pdf | |
| 06/15/2017 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021226s045lbl.pdf | |
| 06/15/2017 | SUPPL-45 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021226s045lbl.pdf | |
| 11/22/2016 | SUPPL-43 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s043lbl.pdf | |
| 11/22/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s043lbl.pdf | |
| 09/15/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s044lbl.pdf | |
| 09/15/2016 | SUPPL-44 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s044lbl.pdf | |
| 11/10/2015 | SUPPL-42 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s042lbl.pdf | |
| 11/10/2015 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s042lbl.pdf | |
| 06/26/2015 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s040lbl.pdf | |
| 06/26/2015 | SUPPL-40 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s040lbl.pdf | |
| 06/26/2015 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s040lbl.pdf | |
| 06/26/2015 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s040lbl.pdf | |
| 03/27/2015 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s041lbl.pdf | |
| 03/27/2015 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s041lbl.pdf | |
| 11/07/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s038lbl.pdf | |
| 11/07/2013 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s038lbl.pdf | |
| 01/17/2013 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s037lbl.pdf | |
| 01/17/2013 | SUPPL-37 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s037lbl.pdf | |
| 06/27/2012 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s036lbl.pdf | |
| 06/27/2012 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s036lbl.pdf | |
| 02/17/2012 | SUPPL-35 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s035lbl.pdf | |
| 04/27/2010 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021226s030lbl.pdf | |
| 09/26/2007 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s022lbl.pdf | |
| 07/09/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s020lbl.pdf | |
| 04/20/2007 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s018lbl.pdf | |
| 12/21/2006 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021226s019lbl.pdf | |
| 04/29/2005 | SUPPL-16 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s016lbl.pdf | |
| 03/28/2005 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s017,021251s011lbl.pdf | |
| 10/19/2004 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21226s014,21251s010lbl.pdf | |
| 12/03/2003 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21226slr012,21251slr009_kaletra_lbl.pdf | |
| 11/27/2002 | SUPPL-6 | 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-3 | 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/2000/21226lbl.pdf |