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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022051
Company: HALEON US HOLDINGS

Products on NDA 022051

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022051

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
11/15/2023	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022051Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022051Orig1s021ltr.pdf
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.

Labels for NDA 022051

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2023	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022051Orig1s021lbl.pdf
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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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	HALEON US HOLDINGS

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