Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020711
Company: GLAXOSMITHKLINE
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| ZYBAN | BUPROPION HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 03/09/2021 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020711s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020711Orig1s052ltr.pdf | |
| 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 | REMS-Proposal, Labeling |
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 |
|---|---|---|---|---|---|
| 03/09/2021 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020711s052lbl.pdf | |
| 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 |