Application 020833

Type: NDA
Sponsor: GLAXO GRP LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLOVENT DISKUS 50	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.05MG/INH	Yes	Yes
002	FLOVENT DISKUS 100	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.1MG/INH	Yes	Yes
003	FLOVENT DISKUS 250	FLUTICASONE PROPIONATE	POWDER;INHALATION	0.25MG/INH	Yes	Yes

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

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	RLD / RS	Approval date
N020833-001	FLOVENT DISKUS 50	FLUTICASONE PROPIONATE	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29
N020833-002	FLOVENT DISKUS 100	FLUTICASONE PROPIONATE	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29
N020833-003	FLOVENT DISKUS 250	FLUTICASONE PROPIONATE	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29

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 · 123 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	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020833-002	FLOVENT DISKUS 100	0.1MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020833-003	FLOVENT DISKUS 250	0.25MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020833-001	FLOVENT DISKUS 50	0.05MG/INH	POWDER / INHALATION	RLD, RS	2000-09-29	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	Sportpharm LLC	348cbd8c-edeb-499c-961d-3aeb5cc2cef1	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	da4e897e-9be1-499a-8889-15398b30ef3b	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	64d669da-559c-40f5-b649-2ce164c211ea	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833
FLOVENT DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	038e6c40-9421-40ef-874b-8f4d7110a74a	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833 ndc (product): 50090-1245
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	Prasco Laboratories	44d009ba-d4b8-410f-b2bc-71ab2d05ac9e	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833
FLOVENT DISKUS	FLUTICASONE PROPIONATE	Proficient Rx LP	816e929e-6ba0-437d-80bb-00068419ed53	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020833 application number: NDA020833 ndc (product): 63187-957

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0600	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0600	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0600	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0600	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0600	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0600	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0600	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0601	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0601	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0601	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0601	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0601	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0601	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0601	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0602	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0602	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0602	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0602	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0602	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0602	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0602	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
50090-1245	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
63187-957	FLOVENT	fluticasone propionate	Proficient Rx LP	NDA	Current
63187-957	FLOVENT	fluticasone propionate	Proficient Rx LP	NDA	Current
76519-1177	FLOVENT	FLUTICASONE PROPIONATE	H.J. Harkins Company, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57516	SUPPL	2019-02-13
57133	SUPPL	2019-01-08
49038	SUPPL	2017-07-21
49026	SUPPL	2017-07-20
45594	SUPPL	2016-10-07
45509	SUPPL	2016-10-06
13554	SUPPL	2016-08-02
3500	SUPPL	2016-08-01
25993	SUPPL	2014-11-14
35467	SUPPL	2014-04-16
3499	SUPPL	2014-04-16
25992	SUPPL	2010-05-05
35466	SUPPL	2010-05-04
13553	SUPPL	2005-09-15
3498	SUPPL	2005-09-15
35465	SUPPL	2005-08-03
25991	SUPPL	2005-08-03
13552	SUPPL	2004-12-30
3497	SUPPL	2004-12-30
41738	ORIG	2004-12-07
25990	SUPPL	2002-11-01
3496	SUPPL	2002-11-01
3495	ORIG	2000-09-29