Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020121
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLONASE FLUTICASONE PROPIONATE 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SPRAY, METERED;NASAL Discontinued None Yes No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
10/19/1994 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
01/07/2019 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020121s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020121Orig1s045ltr.pdf
01/23/2015 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020121s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020121Orig1s044ltr.pdf
06/17/2014 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/17/2014 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/19/2013 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/26/2004 SUPPL-30 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
05/01/2003 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020121s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20121se8-028ltr.pdf
05/07/2002 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/04/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/2002 SUPPL-23 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20121s023ltr.pdf
07/09/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2002 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf
08/03/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/17/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2002 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf
02/18/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/09/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf
10/01/1998 SUPPL-10 Labeling

Label is not available on this site.

12/11/1998 SUPPL-9 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121-S009_FLONASE_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20121s9ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121S009_Flonase.cfm
09/26/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1997 SUPPL-5 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20121.pdf
12/12/1996 SUPPL-4 Labeling

Label is not available on this site.

03/27/1996 SUPPL-3 Labeling

Label is not available on this site.

08/01/1995 SUPPL-2 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-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020121s045lbl.pdf
01/23/2015 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020121s044lbl.pdf
03/26/2004 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flonase_lbl.pdf
05/01/2003 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020121s028lbl.pdf
12/11/1998 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121-S009_FLONASE_prntlbl.pdf

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