Application 205434

Type: NDA
Sponsor: GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	SPRAY, METERED;NASAL	0.05MG/SPRAY	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205434-001	FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD	2014-07-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	Haleon US Holdings LLC	b6134ba0-b70a-4eac-9a82-cef64b242c1d	2024-12-19	Warnings	Exact identifier application applno (NDA): 205434 application number: NDA205434 ndc (product): 0135-0576
CHILDRENS FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	Haleon US Holdings LLC	fab7a1f4-75e0-416f-9644-07aff08e6ab0	2024-03-05	Warnings	Exact identifier application applno (NDA): 205434 application number: NDA205434 ndc (product): 0135-0582
CHILDRENS FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	Haleon US Holdings LLC	3adff80f-fca7-4cc5-b106-0f68f71c85b0	2024-02-08	Warnings	Exact identifier application applno (NDA): 205434 application number: NDA205434 ndc (product): 0135-0582

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0576	FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0576	FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0576	FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0576	FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0576	FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0582	CHILDRENS FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0582	CHILDRENS FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0582	CHILDRENS FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0582	CHILDRENS FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0582	CHILDRENS FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0582	CHILDRENS FLONASE	fluticasone propionate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
50090-1978	FLONASE	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-1978	FLONASE	fluticasone propionate	A-S Medication Solutions	NDA	Current
70518-1223	FLONASE	fluticasone propionate	REMEDYREPACK INC.	NDA	Current
70518-1223	FLONASE	fluticasone propionate	REMEDYREPACK INC.	NDA	Current
70518-1223	FLONASE	fluticasone propionate	REMEDYREPACK INC.	NDA	Current
70518-1223	FLONASE	fluticasone propionate	REMEDYREPACK INC.	NDA	Current
70518-1223	FLONASE	fluticasone propionate	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84547	SUPPL	2025-12-23
84510	SUPPL	2025-12-23
80838	SUPPL	2025-01-13
80837	SUPPL	2025-01-13
80019	SUPPL	2024-10-28
80018	SUPPL	2024-10-28
76588	SUPPL	2023-11-16
76580	SUPPL	2023-11-16
49655	SUPPL	2017-09-01
49654	SUPPL	2017-09-01
22988	ORIG	2016-03-18
19646	SUPPL	2015-12-09
32674	SUPPL	2015-11-27
19645	SUPPL	2015-10-15
32673	SUPPL	2015-10-02
40467	ORIG	2014-07-25
10447	ORIG	2014-07-25