Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205434
Company: GLAXOSMITHKLINE CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLONASE ALLERGY RELIEF FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter 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
07/23/2014 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205434Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205434Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205434Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2017 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205434Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205434Orig1s005ltr.pdf
11/25/2015 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205434Orig1s003ltr.pdf
09/22/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/30/2015 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434Orig1s001lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205434Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/31/2017 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205434Orig1s005lbl.pdf
11/25/2015 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434s003lbl.pdf
09/30/2015 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434Orig1s001lbledt.pdf
07/23/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205434Orig1s000lbl.pdf

FLONASE ALLERGY RELIEF

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.05MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
FLONASE ALLERGY RELIEF FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 205434 GLAXOSMITHKLINE CONS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 208150 APOTEX
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 208024 HI TECH
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 207957 WEST-WARD PHARMS INT

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