Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020548
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOVENT FLUTICASONE PROPIONATE 0.044MG/INH AEROSOL, METERED;INHALATION Discontinued None No No
FLOVENT FLUTICASONE PROPIONATE 0.11MG/INH AEROSOL, METERED;INHALATION Discontinued None No No
FLOVENT FLUTICASONE PROPIONATE 0.22MG/INH AEROSOL, METERED;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
03/27/1996 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
03/26/2004 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20548slr020,20121slr030_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr.pdf
10/08/2003 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr019_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20548slr019LTR.pdf
06/20/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr016_flovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20548slr016,015ltr.pdf
08/15/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/17/2000 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1998 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf
11/04/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1997 SUPPL-3 Labeling

Label is not available on this site.

06/05/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1996 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-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20548slr020,20121slr030_flovent_lbl.pdf
10/08/2003 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr019_flovent_lbl.pdf
06/20/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr016_flovent_lbl.pdf

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