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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020548
Company: GLAXOSMITHKLINE

Products on NDA 020548

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLOVENT	FLUTICASONE PROPIONATE	0.044MG/INH	AEROSOL, METERED;INHALATION	Discontinued	None	No	No
FLOVENT	FLUTICASONE PROPIONATE	0.11MG/INH	AEROSOL, METERED;INHALATION	Discontinued	None	No	No
FLOVENT	FLUTICASONE PROPIONATE	0.22MG/INH	AEROSOL, METERED;INHALATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020548

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/1996	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2004	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20548slr020,20121slr030_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr.pdf
10/08/2003	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr019_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20548slr019LTR.pdf
06/20/2003	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr016_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20548slr016,015ltr.pdf
08/15/2001	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/17/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
12/22/1998	SUPPL-8	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf
11/04/1998	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
07/31/1998	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/13/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/18/1998	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
10/14/1997	SUPPL-3	Labeling		Label is not available on this site.
06/05/1996	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/07/1996	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020548

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2004	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20548slr020,20121slr030_flovent_lbl.pdf
10/08/2003	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr019_flovent_lbl.pdf
06/20/2003	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr016_flovent_lbl.pdf

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