Application 020548

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLOVENT	FLUTICASONE PROPIONATE	AEROSOL, METERED;INHALATION	0.044MG/INH	No	No
002	FLOVENT	FLUTICASONE PROPIONATE	AEROSOL, METERED;INHALATION	0.11MG/INH	No	No
003	FLOVENT	FLUTICASONE PROPIONATE	AEROSOL, METERED;INHALATION	0.22MG/INH	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N020548-001	FLOVENT	FLUTICASONE PROPIONATE	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27
N020548-002	FLOVENT	FLUTICASONE PROPIONATE	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27
N020548-003	FLOVENT	FLUTICASONE PROPIONATE	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020548-002	FLOVENT	0.11MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020548-003	FLOVENT	0.22MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020548-001	FLOVENT	0.044MG/INH	AEROSOL, METERED / INHALATION	1996-03-27	`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 2 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	FLUTICASONE PROPIONATE	P & L Development, LLC	f83fabaa-1c6c-4a19-9f30-2f06df6d48f4	2026-05-26	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Mucinex Nasal Congestion and Allergy Relief	FLUTICASONE PROPIONATE	Reckitt Benckiser LLC	47d8bb65-0bff-f24d-e063-6394a90affaf	2026-05-20	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Equate Childrens Allergy Relief	FLUTICASONE PROPIONATE	WALMART INC.	7e6949aa-66a7-4288-9990-3ad2ece1df3d	2026-05-19	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
XHANCE	FLUTICASONE PROPIONATE	Paratek Pharmaceuticals, Inc.	44fcea33-8cfa-3a5c-e063-6394a90aafb2	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	da4e897e-9be1-499a-8889-15398b30ef3b	2026-05-14	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate ALLERGY RELIEF	FLUTICASONE PROPIONATE	GLENMARK THERAPEUTICS INC., USA	5494106f-6792-409e-b63f-b63b98140959	2026-05-05	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	f4b9fcfc-f3f7-4ce0-8f97-3d475081aa67	2026-04-29	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
childrens allergy relief	FLUTICASONE PROPIONATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4b1d223a-723b-4569-9505-da727691bc56	2026-04-29	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
CareOne Allergy Relief	FLUTICASONE PROPIONATE	American Sales Company	587d7c72-a70e-4ada-945d-14989b96350c	2026-04-23	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
careone childrens allergy relief	FLUTICASONE PROPIONATE	American Sales Company	45ffaf45-8b88-44ba-804b-c2b563589898	2026-04-23	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals Inc.	0a3447a1-407c-40a8-99bb-7e9a86eb37df	2026-04-22	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals, Inc.	4916301d-bcc8-4cd1-86b4-7bf0aecfbf68	2026-04-22	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Up and Up Allergy Relief Nasal	FLUTICASONE PROPIONATE	Target Corporation	51c0a953-93cb-4d0a-b51c-02d9482d1746	2026-04-20	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Good Sense 24 hour allergy nasal	FLUTICASONE PROPIONATE	L. Perrigo Company	783ce1b9-27e4-428a-9f5e-04e70b234ac9	2026-04-09	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
allergy relief	FLUTICASONE PROPIONATE	Safeway	7b5547e1-af4d-4ba9-bd92-524aa11a0ecf	2026-04-01	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Glenmark Pharmaceuticals Inc., USA	27a9b531-f0fd-44ee-b197-ac4b7d64b30c	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate spray, metered	FLUTICASONE PROPIONATE	Chartwell RX, LLC	71a2609f-c4b9-49b0-8185-83c20c22e1d6	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Direct_RX	8b9f7474-8d89-b3e6-e053-2995a90aeddb	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Grocery Outlet	838bbb29-0aa3-4c88-a10d-81be71c20211	2026-03-16	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	IPG Pharmaceuticals, Inc.	f1965bd9-1851-4be5-bbe0-71dd59e034d5	2026-03-16	Warnings, Adverse reactions	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
25154	SUPPL	2004-04-07
12711	SUPPL	2004-04-05
12710	SUPPL	2003-10-16
2703	SUPPL	2003-10-16
34810	SUPPL	2003-07-08
25153	SUPPL	2003-07-06
20713	SUPPL	1998-12-22
63715	ORIG	1900-01-01
51956	ORIG	1900-01-01
51955	ORIG	1900-01-01
51954	ORIG	1900-01-01
51953	ORIG	1900-01-01
51952	ORIG	1900-01-01
51951	ORIG	1900-01-01
51950	ORIG	1900-01-01
51948	ORIG	1900-01-01