Application 020121

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLONASE	FLUTICASONE PROPIONATE	SPRAY, METERED;NASAL	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020121-001	FLONASE	FLUTICASONE PROPIONATE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1994-10-19

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020121-001	FLONASE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	1994-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020121-001	FLONASE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	1994-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`f41ea6bd6efb…`

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 7 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate	FLUTICASONE PROPIONATE	Asclemed USA, Inc.	75049554-64ca-4efa-b8d1-13cf31d0ff90	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Cosette Pharmaceuticals, Inc.	14c8d082-b301-8f09-a509-950459ae0a28	2022-05-05	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Glenmark Pharmaceuticals Inc., USA	3c7b3482-e2fd-4857-9394-a47fd7f4c47b	2020-02-01	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Proficient Rx LP	96af29b8-16b4-4113-9ec3-338438e11a49	2019-11-01	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLOVENT DISKUS	FLUTICASONE PROPIONATE	Proficient Rx LP	816e929e-6ba0-437d-80bb-00068419ed53	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Selder, S.A. de C.V.	2da4ba91-c356-473d-b20c-5bb9265767df	2017-11-29	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	4e1cd546-4598-115b-0357-5d0c22731faa	2017-11-17	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57512	SUPPL	2019-02-13
57134	SUPPL	2019-01-08
12230	SUPPL	2015-01-30
21180	SUPPL	2015-01-26
41146	SUPPL	2010-05-25
21179	SUPPL	2004-04-07
12229	SUPPL	2004-04-05
2037	SUPPL	2003-05-30
34276	SUPPL	2003-05-06
2036	SUPPL	2002-05-23
21178	SUPPL	2002-05-09
2035	SUPPL	2002-05-09
2034	SUPPL	2002-05-09
41147	SUPPL	1998-12-11
12228	SUPPL	1998-12-11
2033	SUPPL	1998-12-11
53096	ORIG	1900-01-01
53095	ORIG	1900-01-01
53094	ORIG	1900-01-01
53093	ORIG	1900-01-01
53092	ORIG	1900-01-01
53091	ORIG	1900-01-01
53090	ORIG	1900-01-01
53089	ORIG	1900-01-01
53088	ORIG	1900-01-01