Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022051
Company: GLAXOSMITHKLINE CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLONASE SENSIMIST ALLERGY RELIEF FLUTICASONE FUROATE 0.0275MG/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
04/27/2007 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022051_veramyst_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/23/2017 SUPPL-17 Labeling-Container/Carton Labels Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022051Orig1s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/022051Orig1s017.pdf
04/05/2017 SUPPL-14 Labeling-Container/Carton Labels Label (PDF)
Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014ltr.pdf
08/02/2016 SUPPL-13 Efficacy-Rx To OTC Switch Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022051Orig1s013lbl.pdf
05/21/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

08/21/2012 SUPPL-8 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

10/13/2011 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/01/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/28/2009 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/05/2017 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014lbl.pdf
04/05/2017 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014ltr.pdf
08/02/2016 SUPPL-13 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022051Orig1s013lbl.pdf

FLONASE SENSIMIST 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; 0.0275MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
FLONASE SENSIMIST ALLERGY RELIEF FLUTICASONE FUROATE 0.0275MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 022051 GLAXOSMITHKLINE CONS

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