Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021077
Company: GLAXO GRP LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVAIR DISKUS 100/50 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription None Yes Yes
ADVAIR DISKUS 250/50 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER;INHALATION Prescription None Yes Yes
ADVAIR DISKUS 500/50 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.5MG/INH;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
08/24/2000 ORIG-1 Approval Type 4 - New Combination STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21077_AdvairDiskus.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2017 SUPPL-58 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021077Orig1s058ltr.pdf
04/29/2016 SUPPL-54 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021077Orig1s054ltr.pdf
11/13/2014 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s053ltr.pdf
06/17/2014 SUPPL-52 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021077Orig1s052.pdf
04/14/2014 SUPPL-51 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021077Orig1s051.pdf
06/19/2013 SUPPL-50 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021077Orig1s050.pdf
08/09/2012 SUPPL-49 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-48 Labeling

Label is not available on this site.

06/27/2011 SUPPL-47 REMS-Assessment, 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-46 REMS-Assessment, REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf
06/25/2010 SUPPL-42 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021077s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf
01/04/2011 SUPPL-41 REMS-Assessment, REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s041ltr.pdf
03/31/2009 SUPPL-36 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021077s036ltr.pdf
04/30/2008 SUPPL-29 REMS-Proposal, Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021077029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021077se2-029_SUMR.pdf
03/02/2006 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029ltr.pdf
02/23/2007 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021077s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028, 021077s027ltr.pdf
09/27/2006 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s026LTR.pdf
09/28/2004 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021077s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf
08/11/2003 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077slr019_advair_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077slr019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_s019_ADVAIR DISKUS.pdf
04/21/2004 SUPPL-17 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21077se5-017_advair_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077se5-017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021077Orig1s017.pdf
05/17/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21077slr008ltr.pdf
10/16/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/2003 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077se1-003_advair_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077se1-003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077Orig1S003.pdf
12/22/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2017 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s058lbl.pdf
02/28/2017 SUPPL-58 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021077s058lbl.pdf
04/29/2016 SUPPL-54 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077s054lbl.pdf
11/13/2014 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s053lbl.pdf
04/14/2014 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf
04/14/2014 SUPPL-51 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf
06/25/2010 SUPPL-42 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021077s042lbl.pdf
04/30/2008 SUPPL-29 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf
04/30/2008 SUPPL-29 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf
02/23/2007 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021077s027lbl.pdf
09/27/2006 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s026lbl.pdf
03/02/2006 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s028lbl.pdf
09/28/2004 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021077s022lbl.pdf
04/21/2004 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21077se5-017_advair_lbl.pdf
11/17/2003 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077se1-003_advair_lbl.pdf
08/11/2003 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077slr019_advair_lbl.pdf

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