Application 022051

Type: NDA
Sponsor: GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	FLONASE SENSIMIST ALLERGY RELIEF	FLUTICASONE FUROATE	SPRAY, METERED;NASAL	0.0275MG/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
N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	FLUTICASONE FUROATE	0.0275MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2016-08-02

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022051-002	8062264	2026-04-05	Drug product	2016-08-31
N022051-002	8347879	2028-07-15	Drug product	2016-08-31
N022051-002	8147461	2028-10-15	Drug product	2016-08-31

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	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022051-002	FLONASE SENSIMIST ALLERGY RELIEF	0.0275MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2016-08-02	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022051-002	9320862	2024-11-06	Drug product	2016-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022051-002	9320862	2024-11-06	Drug product	2016-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022051-002	9320862	2024-11-06	Drug product	2016-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022051-002	9320862	2024-11-06	Drug product	2016-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022051-002	9320862	2024-11-06	Drug product	2016-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022051-002	9320862	2024-11-06	Drug product	2016-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022051-002	8062264	2026-04-05	Drug product	2016-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022051-002	8347879	2028-07-15	Drug product	2016-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022051-002	8147461	2028-10-15	Drug product	2016-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022051-002	9320862	2024-11-06	Drug product	2016-08-31	`301d65b070ca…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLONASE SENSIMIST ALLERGY RELIEF	FLUTICASONE FUROATE	Haleon US Holdings LLC	107100af-7ca2-44e8-b067-c0ab0a19a6dc	2024-12-19	Warnings	Exact identifier application applno (NDA): 022051 application number: NDA022051 ndc (product): 0135-0615
FLONASE SENSIMIST ALLERGY RELIEF	FLUTICASONE FUROATE	Haleon US Holdings LLC	893234b5-be82-4425-b850-2b884637b18e	2024-03-05	Warnings	Exact identifier application applno (NDA): 022051 application number: NDA022051 ndc (product): 0135-0616
FLONASE SENSIMIST ALLERGY RELIEF	FLUTICASONE FUROATE	A-S Medication Solutions	a008dc12-c21b-456e-9824-fcc5ce64d4ba	2023-11-17	Warnings	Exact identifier application applno (NDA): 022051 application number: NDA022051 ndc (product): 50090-6075
FLONASE SENSIMIST ALLERGY RELIEF	FLUTICASONE FUROATE	A-S Medication Solutions	51fe1787-6425-4df0-9890-e7f34651be35	2023-10-31	Warnings	Exact identifier application applno (NDA): 022051 application number: NDA022051 ndc (product): 50090-5967

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0615	FLONASE SENSIMIST	fluticasone furoate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0615	FLONASE SENSIMIST	fluticasone furoate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0615	FLONASE SENSIMIST	fluticasone furoate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0616	FLONASE SENSIMIST	fluticasone furoate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0616	FLONASE SENSIMIST	fluticasone furoate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0616	FLONASE SENSIMIST	fluticasone furoate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0173-0753	VERAMYST	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
50090-5967	FLONASE SENSIMIST	fluticasone furoate	A-S Medication Solutions	NDA	Current
50090-6075	FLONASE SENSIMIST	fluticasone furoate	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84546	SUPPL	2025-12-23
84508	SUPPL	2025-12-23
83356	SUPPL	2025-09-16
83355	SUPPL	2025-09-16
80841	SUPPL	2025-01-13
80835	SUPPL	2025-01-13
80020	SUPPL	2024-10-28
80017	SUPPL	2024-10-28
76587	SUPPL	2023-11-16
76579	SUPPL	2023-11-16
54300	SUPPL	2018-05-22
52689	ORIG	2018-02-23
49578	SUPPL	2017-08-29
47956	SUPPL	2017-04-12
47939	SUPPL	2017-04-12
45883	SUPPL	2016-11-10