Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021433
Company: GLAXO GRP LTD
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 |
---|---|---|---|---|---|
08/18/2021 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021433Orig1s040ReplacementLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021433Orig1s040ReplacementLtr.pdf | |
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 |
---|---|---|---|---|---|
08/18/2021 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021433Orig1s040ReplacementLbl.pdf | |
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 |