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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205434
Company: HALEON US HOLDINGS

Products on NDA 205434

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	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205434

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
10/24/2024	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022051Orig1s023, 205434Orig1s016Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022051Orig1s023, 205434Orig1s016ltr.pdf
11/15/2023	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205434Origs015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205434Origs015ltr.pdf
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

Labels for NDA 205434

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2024	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022051Orig1s023, 205434Orig1s016Lbl.pdf
11/15/2023	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205434Origs015lbl.pdf
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

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

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	HALEON US HOLDINGS
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	217088	AUROBINDO PHARMA LTD
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	207957	HIKMA

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