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| ZYBAN | BUPROPION HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| 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 |