Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020692
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEREVENT | SALMETEROL XINAFOATE | EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/19/1997 | 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/97/020692s000_SereventTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/22/2019 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020692s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020692Orig1s047ltr.pdf | |
| 12/21/2018 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020692s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020692Orig1s046ltr.pdf | |
| 09/30/2016 | SUPPL-45 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020692s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020692Orig1s045ltr.pdf | |
| 06/17/2016 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/2014 | SUPPL-43 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020692s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020692Orig1s043ltr.pdf | |
| 08/09/2012 | SUPPL-42 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf |
| 08/09/2012 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/27/2011 | SUPPL-39 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf |
| 05/10/2011 | SUPPL-38 | REMS-Assessment, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf | |
| 06/25/2010 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf | |
| 11/18/2010 | SUPPL-35 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s035ltr.pdf |
| 12/30/2010 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s032ltr.pdf | |
| 03/20/2008 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031ltr.pdf | |
| 03/02/2006 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020692s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029ltr.pdf | |
| 02/23/2007 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020692s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028, 021077s027ltr.pdf | |
| 09/28/2004 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20236s030,20692s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf | |
| 08/11/2003 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20692slr024_serevent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20692slr024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020692_s024_SEREVENT DISKUS.pdf | |
| 05/17/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/2002 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20692s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20692s016ltr.pdf | |
| 05/17/2001 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/15/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/2000 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 07/20/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/03/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/18/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-2 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.cfm | |
| 09/25/1998 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/22/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020692s047lbl.pdf | |
| 12/21/2018 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020692s046lbl.pdf | |
| 09/30/2016 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020692s045lbl.pdf | |
| 04/14/2014 | SUPPL-43 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020692s043lbl.pdf | |
| 04/14/2014 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020692s043lbl.pdf | |
| 05/10/2011 | SUPPL-38 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf | |
| 05/10/2011 | SUPPL-38 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf | |
| 12/30/2010 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s032lbl.pdf | |
| 06/25/2010 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s036lbl.pdf | |
| 06/25/2010 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s036lbl.pdf | |
| 03/20/2008 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf | |
| 02/23/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020692s028lbl.pdf | |
| 03/02/2006 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020692s029lbl.pdf | |
| 09/28/2004 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20236s030,20692s026lbl.pdf | |
| 08/11/2003 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20692slr024_serevent_lbl.pdf | |
| 03/22/2002 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20692s16lbl.pdf | |
| 09/25/1998 | SUPPL-2 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf | |
| 09/25/1998 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf |