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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021433
Company: GLAXO GRP LTD

Products on NDA 021433

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLOVENT HFA	FLUTICASONE PROPIONATE	0.22MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes
FLOVENT HFA	FLUTICASONE PROPIONATE	0.11MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes
FLOVENT HFA	FLUTICASONE PROPIONATE	0.044MG/INH	AEROSOL, METERED;INHALATION	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021433

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21433_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21433ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021433s000_FloventHFATOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2021	SUPPL-40	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021433Orig1s040ReplacementLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021433Orig1s040ReplacementLtr.pdf
01/07/2019	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021433s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021433Orig1s034ltr.pdf
07/19/2017	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021433s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020833Orig1s033,021433Orig1s033ltr.pdf
10/05/2016	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021433Orig1s032ltr.pdf
07/28/2016	SUPPL-31	Labeling-Container/Carton Labels, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021433Orig1s031ltr.pdf
05/20/2016	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
01/06/2016	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
12/10/2014	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021433Orig1s026ltr.pdf
11/14/2014	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021433Orig1s025ltr.pdf
06/17/2014	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
06/17/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
07/18/2013	SUPPL-22	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021433s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021433Orig1s022ltr.pdf
06/19/2013	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
07/28/2011	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021433s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021433s019ltr.pdf
11/03/2010	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021433s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021433s015ltr.pdf
07/01/2008	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021433s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021433s011ltr.pdf
10/25/2006	SUPPL-6	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021433s006ltr.pdf
12/21/2005	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021433s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021433s005rev2.pdf
02/28/2006	SUPPL-4	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021433s004ltr.pdf

Labels for NDA 021433

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2021	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021433Orig1s040ReplacementLbl.pdf
01/07/2019	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021433s034lbl.pdf
07/19/2017	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021433s033lbl.pdf
10/05/2016	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s032lbl.pdf
07/28/2016	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s031lbl.pdf
07/28/2016	SUPPL-31	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s031lbl.pdf
12/10/2014	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s026lbl.pdf
11/14/2014	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s025lbl.pdf
07/18/2013	SUPPL-22	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021433s022lbl.pdf
07/28/2011	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021433s019lbl.pdf
11/03/2010	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021433s015lbl.pdf
07/01/2008	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021433s011lbl.pdf
10/25/2006	SUPPL-6	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s006lbl.pdf
02/28/2006	SUPPL-4	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s004lbl.pdf
12/21/2005	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021433s005lbl.pdf
05/14/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21433_flovent_lbl.pdf

Therapeutic Equivalents for NDA 021433

FLOVENT HFA

AEROSOL, METERED;INHALATION; 0.044MG/INH
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLOVENT HFA	FLUTICASONE PROPIONATE	0.044MG/INH	AEROSOL, METERED;INHALATION	Prescription	Yes	AB	021433	GLAXO GRP LTD
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.044MG/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB	219602	GLENMARK SPECLT

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