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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020833
Company: GLAXO GRP LTD

Products on NDA 020833

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLOVENT DISKUS 100	FLUTICASONE PROPIONATE	0.1MG/INH	POWDER;INHALATION	Prescription	None	Yes	Yes
FLOVENT DISKUS 250	FLUTICASONE PROPIONATE	0.25MG/INH	POWDER;INHALATION	Prescription	None	Yes	Yes
FLOVENT DISKUS 50	FLUTICASONE PROPIONATE	0.05MG/INH	POWDER;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020833

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20833ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-833_Flovent.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2019	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020833s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020833Orig1s034ltr.pdf
07/19/2017	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020833s033lbl.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/2016/020833s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020833Orig1s032ltr.pdf
07/28/2016	SUPPL-31	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020833Orig1s031ltr.pdf
11/13/2014	SUPPL-30	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020833Orig1s030ltr.pdf
06/17/2014	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
04/14/2014	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020833s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020833Orig1s028ltr.pdf
06/19/2013	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
12/05/2012	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
05/03/2010	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020833s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020833s021ltr.pdf
09/14/2005	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020833s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020833s015ltr.pdf
07/31/2005	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020833s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020833s014ltr.pdf
12/17/2004	SUPPL-12	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20833s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20833s012ltr.pdf
11/01/2002	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20833slr008ltr.pdf
05/15/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/01/2002	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20833slr002ltr.pdf
04/05/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020833

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2019	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020833s034lbl.pdf
07/19/2017	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020833s033lbl.pdf
10/05/2016	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s032lbl.pdf
07/28/2016	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s031lbl.pdf
07/28/2016	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s031lbl.pdf
04/14/2014	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020833s028lbl.pdf
05/03/2010	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020833s021lbl.pdf
09/14/2005	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020833s015lbl.pdf
07/31/2005	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020833s014lbl.pdf
12/17/2004	SUPPL-12	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20833s012lbl.pdf

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