Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020549
Company: GLAXOSMITHKLINE
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
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English