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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020549
Company: GLAXOSMITHKLINE

Products on NDA 020549

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLOVENT	FLUTICASONE PROPIONATE	0.044MG/INH	POWDER;INHALATION	Discontinued	None	No	No
FLOVENT	FLUTICASONE PROPIONATE	0.088MG/INH	POWDER;INHALATION	Discontinued	None	No	No
FLOVENT	FLUTICASONE PROPIONATE	0.22MG/INH	POWDER;INHALATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020549

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020549ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2004	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flonase_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr.pdf
10/08/2003	SUPPL-14	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr014_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20549slr014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf
06/20/2003	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr012_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20549slr012ltr.pdf
08/27/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/29/2001	SUPPL-8	Labeling		Label is not available on this site.
05/17/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
07/19/1999	SUPPL-6	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20549-S006_Flovent.pdf
04/23/1999	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
12/22/1998	SUPPL-2	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf
12/03/1998	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020549

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2004	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flonase_lbl.pdf
10/08/2003	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr014_flovent_lbl.pdf
06/20/2003	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr012_flovent_lbl.pdf

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