Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020692
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English