Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021254
Company: GLAXO GRP LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVAIR HFA FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.045MG/INH;EQ 0.021MG BASE/INH AEROSOL, METERED;INHALATION Prescription None Yes Yes
ADVAIR HFA FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.115MG/INH;EQ 0.021MG BASE/INH AEROSOL, METERED;INHALATION Prescription None Yes Yes
ADVAIR HFA FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.23MG/INH;EQ 0.021MG BASE/INH AEROSOL, METERED;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
06/08/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021254lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021254s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021254s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2017 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021254Orig1s026ltr.pdf
12/10/2014 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s024ltr.pdf
11/13/2014 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s023ltr.pdf
06/17/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/17/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/19/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/09/2012 SUPPL-19 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-18 Labeling

Label is not available on this site.

06/27/2011 SUPPL-16 REMS-Modified, REMS-Assessment 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-15 REMS-Modified, REMS-Assessment 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-13 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021254s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf
01/04/2011 SUPPL-12 REMS-Modified, REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021254s012ltr.pdf
12/19/2012 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021254s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021254Orig1s009ltr.pdf
09/15/2009 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021254s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021254s007ltr.pdf
07/31/2008 SUPPL-4 Labeling-Container/Carton Labels, REMS-Proposal, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s004ltr.pdf
03/20/2008 SUPPL-3 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2017 SUPPL-26 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s026lbl.pdf
02/28/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s026lbl.pdf
12/10/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s024lbl.pdf
11/13/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s023lbl.pdf
12/19/2012 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021254s009lbl.pdf
05/10/2011 SUPPL-15 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf
05/10/2011 SUPPL-15 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf
06/25/2010 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021254s013lbl.pdf
06/25/2010 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021254s013lbl.pdf
09/15/2009 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021254s007lbl.pdf
03/20/2008 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf
06/08/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021254lbl.pdf

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