Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020833
Company: GLAXO GRP LTD
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
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-Container/Carton Labels, Labeling-Package Insert 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.

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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020833s031lbl.pdf
07/28/2016 SUPPL-31 Labeling-Package Insert 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

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