Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020711
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYBAN BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ZYBAN BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes 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
05/14/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020711_zyban_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/19/2019 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020711s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020711Orig1s048ltr.pdf
05/04/2017 SUPPL-47 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020711Orig1s045,s046,s047ltr.pdf
05/04/2017 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020711Orig1s045,s046,s047ltr.pdf
05/04/2017 SUPPL-45 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020711Orig1s045,s046,s047ltr.pdf
06/01/2016 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020711s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020711Orig1s044ltr.pdf
08/13/2014 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s043ltr.pdf
12/24/2014 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s042ltr.pdf
03/27/2014 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s039ltr.pdf
01/18/2012 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020711s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020711s036ltr.pdf
08/22/2011 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020711s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020711s026,s035ltr.pdf
02/26/2010 SUPPL-34 Labeling, REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020711s034ltr.pdf
07/01/2009 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020711s032,s033ltr.pdf
07/01/2009 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020711s032,s033ltr.pdf
09/20/2010 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/0020711s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020711s031ltr.pdf
08/02/2007 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf
03/22/2007 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020711s028ltr.pdf
11/16/2006 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020711s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s027ltr.pdf
08/22/2011 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020711s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020711s026,s035ltr.pdf
04/28/2006 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s024LTR.pdf
03/13/2006 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s022ltr.pdf
01/12/2005 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf
11/03/2004 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20711s019,020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20711s019,020ltr.pdf
11/03/2004 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20711s019,020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20711s019,020ltr.pdf
02/14/2003 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf
02/15/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/14/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf
02/21/2002 SUPPL-15 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20711s15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020711_S015_ZYBAN.pdf
02/14/2003 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf
02/14/2003 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf
02/07/2001 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20711s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-711SE8-012_Zyban_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-711s12_Zyban.cfm
08/03/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/2000 SUPPL-10 Labeling

Label is not available on this site.

11/28/2000 SUPPL-9 Labeling

Label is not available on this site.

11/28/2000 SUPPL-8 Labeling

Label is not available on this site.

03/05/1999 SUPPL-7 Labeling

Label is not available on this site.

04/07/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/05/1999 SUPPL-5 Labeling

Label is not available on this site.

02/24/1999 SUPPL-4 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020711_s002s004_ZybanTOC.cfm
09/10/1999 SUPPL-3 Efficacy-New Dosing Regimen

Label is not available on this site.

02/24/1999 SUPPL-2 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020711_s002s004_ZybanTOC.cfm
09/10/1999 SUPPL-1 Efficacy-Accelerated Approval Confirmatory Study

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/19/2019 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020711s048lbl.pdf
05/04/2017 SUPPL-47 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf
05/04/2017 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf
05/04/2017 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf
05/04/2017 SUPPL-45 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf
06/01/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020711s044lbl.pdf
12/24/2014 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s042lbl.pdf
08/13/2014 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s043lbl.pdf
03/27/2014 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s039lbl.pdf
01/18/2012 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020711s036lbl.pdf
08/22/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020711s035lbl.pdf
08/22/2011 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020711s026lbl.pdf
09/20/2010 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/0020711s031lbl.pdf
07/01/2009 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf
07/01/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf
08/02/2007 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s029lbl.pdf
03/22/2007 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s028lbl.pdf
11/16/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020711s027lbl.pdf
01/12/2005 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf
11/03/2004 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20711s019,020lbl.pdf
11/03/2004 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20711s019,020lbl.pdf
02/14/2003 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf
02/14/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf
02/14/2003 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf
02/14/2003 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf
02/07/2001 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20711s12lbl.pdf

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