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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021254
Company: GLAXO GRP LTD

Other Important Information from FDA

Products on NDA 021254

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021254

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
08/18/2021	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021254s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021254Orig1s036ltr.pdf
01/07/2019	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021254s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021254Orig1s028ltr.pdf
12/20/2017	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021254Orig1s027ltr.pdf
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-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-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

Labels for NDA 021254

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2021	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021254s036lbl.pdf
01/07/2019	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021254s028lbl.pdf
12/20/2017	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s027lbl.pdf
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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