Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021433
Company: GLAXO GRP LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOVENT HFA FLUTICASONE PROPIONATE 0.22MG/INH AEROSOL, METERED;INHALATION Prescription None Yes Yes
FLOVENT HFA FLUTICASONE PROPIONATE 0.11MG/INH AEROSOL, METERED;INHALATION Prescription None Yes Yes
FLOVENT HFA FLUTICASONE PROPIONATE 0.044MG/INH AEROSOL, METERED;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
05/14/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21433_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21433ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021433s000_FloventHFATOC.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/2019/021433s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021433Orig1s034ltr.pdf
07/19/2017 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021433s033lbl.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/2016/021433s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021433Orig1s032ltr.pdf
07/28/2016 SUPPL-31 Labeling-Container/Carton Labels, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021433Orig1s031ltr.pdf
05/20/2016 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/06/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/10/2014 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021433Orig1s026ltr.pdf
11/14/2014 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021433Orig1s025ltr.pdf
06/17/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/17/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/18/2013 SUPPL-22 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021433s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021433Orig1s022ltr.pdf
06/19/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/28/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021433s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021433s019ltr.pdf
11/03/2010 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021433s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021433s015ltr.pdf
07/01/2008 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021433s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021433s011ltr.pdf
10/25/2006 SUPPL-6 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021433s006ltr.pdf
12/21/2005 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021433s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021433s005rev2.pdf
02/28/2006 SUPPL-4 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021433s004ltr.pdf
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/2019/021433s034lbl.pdf
07/19/2017 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021433s033lbl.pdf
10/05/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s032lbl.pdf
07/28/2016 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s031lbl.pdf
07/28/2016 SUPPL-31 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s031lbl.pdf
12/10/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s026lbl.pdf
11/14/2014 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s025lbl.pdf
07/18/2013 SUPPL-22 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021433s022lbl.pdf
07/28/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021433s019lbl.pdf
11/03/2010 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021433s015lbl.pdf
07/01/2008 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021433s011lbl.pdf
10/25/2006 SUPPL-6 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s006lbl.pdf
02/28/2006 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s004lbl.pdf
12/21/2005 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021433s005lbl.pdf
05/14/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21433_flovent_lbl.pdf

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