Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021226
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-Medication Guide, Labeling-Package Insert 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-Patient Package Insert, Labeling-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-Package Insert, Labeling-Medication Guide 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 Efficacy-Pediatric, Labeling-Medication Guide, Labeling-Package Insert, 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-Medication Guide, Labeling-Package Insert 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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021226s049lbl.pdf
10/21/2020 SUPPL-49 Labeling-Package Insert 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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s044lbl.pdf
09/15/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s044lbl.pdf
11/10/2015 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s042lbl.pdf
11/10/2015 SUPPL-42 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s042lbl.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
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s038lbl.pdf
11/07/2013 SUPPL-38 Labeling-Package Insert 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

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