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PROPIONATE	SPRAY, METERED;NASAL	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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FLONASE	FLUTICASONE PROPIONATE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1994-10-19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N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`84e616aacf4f…`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N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`caaa826d4ba7…`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UTC	2026-02	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`011fe1cb6892…`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this ZIP	2025-12	N020121-001	FLONASE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	1994-10-19	`31067a03dcf5…`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 6 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	Haleon US Holdings LLC	fab7a1f4-75e0-416f-9644-07aff08e6ab0	2024-03-05	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
CHILDRENS FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	Haleon US Holdings LLC	3adff80f-fca7-4cc5-b106-0f68f71c85b0	2024-02-08	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	64d669da-559c-40f5-b649-2ce164c211ea	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	A-S Medication Solutions	4a4b7242-1083-4912-a318-25c3914aaf22	2024-01-11	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLOVENT DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	038e6c40-9421-40ef-874b-8f4d7110a74a	2024-01-11	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	674b1c81-359d-4fc4-8ce6-a53931b171e0	2024-01-02	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLOVENT HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	74563f7b-8512-4b76-8c55-b88b9cd3206b	2023-12-09	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Padagis Israel Pharmaceuticals Ltd	16985600-3f81-4d51-8bf7-0cbbd89856a1	2023-11-30	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	a4e1c265-5205-4089-8190-0755ede83896	2023-11-28	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Cosette Pharmaceuticals, Inc.	e7ef2aaf-749c-66c9-2bdf-7214ab00060e	2023-11-22	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d	2023-11-17	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	Prasco Laboratories	99249b31-bf0a-464f-8335-845279350dbe	2023-09-28	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bryant Ranch Prepack	8bd6f3a4-87f7-449e-8fcc-fec1537fcab3	2023-07-17	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bryant Ranch Prepack	0120296b-bebc-4a2d-8058-6caf41f96e52	2023-07-17	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	Prasco Laboratories	44d009ba-d4b8-410f-b2bc-71ab2d05ac9e	2023-05-31	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	A-S Medication Solutions	e2df3810-3b92-4678-8f62-683c656b1de9	2023-04-16	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Padagis Israel Pharmaceuticals Ltd	78e056e2-d39e-4d20-9ab2-332bd6973619	2022-12-30	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Welby Fluticasone	FLUTICASONE PROPIONATE	Aldi Inc	446bfcd9-8f28-4a96-840f-c72ac5970408	2022-11-03	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
topcare fluticasone propionate nasal	FLUTICASONE PROPIONATE	Topco Associates LLC	f7c425d2-4afb-478f-83bc-eb336910233b	2022-11-01	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
equate allergy relief	FLUTICASONE PROPIONATE	Wal-Mart Stores Inc	959167e8-f4a1-49b9-b3a6-f0d0b3d7d477	2022-10-14	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