Application 204275

Type: NDA
Sponsor: GLAXO GRP LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	POWDER;INHALATION	0.1MG/INH;EQ 0.025MG BASE/INH	Yes	Yes
002	BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	POWDER;INHALATION	0.2MG/INH;EQ 0.025MG BASE/INH	Yes	Yes
003	BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	POWDER;INHALATION	0.05MG/INH;EQ 0.025MG BASE/INH	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N204275-001	BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10
N204275-002	BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30
N204275-003	BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2023-05-12

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204275-001	8511304	2027-06-14	U-1424	Drug product	2013-09-06
N204275-001	8511304	2027-06-14	U-1691	Drug product	2013-09-06
N204275-001	8511304	2027-06-14	U-3623	Drug product	2013-09-06
N204275-001	8511304*PED	2027-12-14		Pediatric extension
N204275-001	11116721	2029-02-26	U-1401	Drug product	2021-10-12
N204275-001	11116721	2029-02-26	U-1691	Drug product	2021-10-12
N204275-001	11116721	2029-02-26	U-3623	Drug product	2021-10-12
N204275-001	11116721*PED	2029-08-26		Pediatric extension
N204275-001	8534281	2030-03-08		Drug product	2013-09-18
N204275-001	8534281*PED	2030-09-08		Pediatric extension
N204275-001	8746242	2030-10-11		Drug product	2014-07-08
N204275-001	8746242*PED	2031-04-11		Pediatric extension
N204275-002	8511304	2027-06-14	U-1691	Drug product	2015-05-07
N204275-002	8511304	2027-06-14	U-3623	Drug product	2015-05-07
N204275-002	8511304*PED	2027-12-14		Pediatric extension
N204275-002	11116721	2029-02-26	U-1691	Drug product	2021-10-12
N204275-002	11116721	2029-02-26	U-3623	Drug product	2021-10-12
N204275-002	11116721*PED	2029-08-26		Pediatric extension
N204275-002	8534281	2030-03-08		Drug product	2015-05-07
N204275-002	8534281*PED	2030-09-08		Pediatric extension
N204275-002	8746242	2030-10-11		Drug product	2015-05-07
N204275-002	8746242*PED	2031-04-11		Pediatric extension
N204275-003	8511304	2027-06-14	U-3623	Drug product	2023-06-09
N204275-003	8511304*PED	2027-12-14		Pediatric extension
N204275-003	11116721	2029-02-26	U-3623	Drug product	2023-06-09
N204275-003	11116721*PED	2029-08-26		Pediatric extension
N204275-003	8534281	2030-03-08		Drug product	2023-06-09
N204275-003	8534281*PED	2030-09-08		Pediatric extension
N204275-003	8746242	2030-10-11		Drug product	2023-06-09
N204275-003	8746242*PED	2031-04-11		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204275-001	NPP	2026-05-13
N204275-001	PED	2026-11-13
N204275-003	NS	2026-05-13
N204275-003	PED	2026-11-13

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 3 · 107 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2023-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2023-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 45 · 1,785 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204275-001	8511304	2027-06-14	U-1691	Drug product	2013-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8511304	2027-06-14	U-1424	Drug product	2013-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8511304	2027-06-14	U-3623	Drug product	2013-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8511304*PED	2027-12-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	11116721	2029-02-26	U-1401	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	11116721	2029-02-26	U-3623	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	11116721	2029-02-26	U-1691	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	11116721*PED	2029-08-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8534281	2030-03-08		Drug product	2013-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8534281*PED	2030-09-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8746242	2030-10-11		Drug product	2014-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8746242*PED	2031-04-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8511304	2027-06-14	U-3623	Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8511304	2027-06-14	U-1691	Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8511304*PED	2027-12-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	11116721	2029-02-26	U-3623	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	11116721	2029-02-26	U-1691	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	11116721*PED	2029-08-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8534281	2030-03-08		Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8534281*PED	2030-09-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8746242	2030-10-11		Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8746242*PED	2031-04-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8511304	2027-06-14	U-3623	Drug product	2023-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8511304*PED	2027-12-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	11116721	2029-02-26	U-3623	Drug product	2023-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	11116721*PED	2029-08-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8534281	2030-03-08		Drug product	2023-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8534281*PED	2030-09-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8746242	2030-10-11		Drug product	2023-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8746242*PED	2031-04-11		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8511304	2027-06-14	U-1691	Drug product	2013-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8511304	2027-06-14	U-1424	Drug product	2013-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8511304	2027-06-14	U-3623	Drug product	2013-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8511304*PED	2027-12-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	11116721	2029-02-26	U-1401	Drug product	2021-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	11116721	2029-02-26	U-3623	Drug product	2021-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	11116721	2029-02-26	U-1691	Drug product	2021-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	11116721*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8534281	2030-03-08		Drug product	2013-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8534281*PED	2030-09-08		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N204275-001	NPP	2026-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	PED	2026-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	NS	2026-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	PED	2026-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204275-001	NPP	2026-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	PED	2026-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-003	NS	2026-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-003	PED	2026-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-001	NPP	2026-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-001	PED	2026-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-003	NS	2026-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-003	PED	2026-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204275-001	NPP	2026-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-001	PED	2026-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-003	NS	2026-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-003	PED	2026-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-001	NPP	2026-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-001	PED	2026-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-003	NS	2026-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-003	PED	2026-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-001	NPP	2026-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-001	PED	2026-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-003	NS	2026-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-003	PED	2026-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-001	NPP	2026-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-001	PED	2026-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-003	NS	2026-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-003	PED	2026-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-001	NPP	2026-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-001	PED	2026-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-003	NS	2026-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-003	PED	2026-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-001	NPP	2026-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-001	PED	2026-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-003	NS	2026-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-003	PED	2026-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-001	NPP	2026-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-001	PED	2026-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-003	NS	2026-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-003	PED	2026-11-13	`d8e5a09893c0…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Furoate and Vilanterol	FLUTICASONE FUROATE AND VILANTEROL	Prasco Laboratories	3a761487-c300-451a-8537-3196c00c11b5	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204275 application number: NDA204275 ndc (product): 66993-135 ndc (product): 66993-136
Breo Ellipta	FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE	GlaxoSmithKline LLC	96428df1-ea05-431a-98d3-1ec2c4b63878	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204275 application number: NDA204275 ndc (product): 0173-0859 ndc (product): 0173-0882

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0859	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0859	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0859	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0859	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0859	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0882	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0882	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0882	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0882	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0882	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
50090-2404	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	A-S Medication Solutions	NDA	Current
66993-135	Fluticasone Furoate and Vilanterol	fluticasone furoate and vilanterol	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-136	Fluticasone Furoate and Vilanterol	fluticasone furoate and vilanterol	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
70518-2028	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	REMEDYREPACK INC.	NDA	Current
70518-2028	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	REMEDYREPACK INC.	NDA	Current
70518-2028	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	REMEDYREPACK INC.	NDA	Current
70518-2028	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	REMEDYREPACK INC.	NDA	Current
70518-2028	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	REMEDYREPACK INC.	NDA	Current
70518-2028	Breo Ellipta	fluticasone furoate and vilanterol trifenatate	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74250	SUPPL	2023-05-15
74241	SUPPL	2023-05-15
57538	SUPPL	2019-02-13
57129	SUPPL	2019-01-08
50879	SUPPL	2017-12-27
50842	SUPPL	2017-12-22
48403	SUPPL	2017-05-17
48387	SUPPL	2017-05-17
45804	SUPPL	2016-11-04
45776	SUPPL	2016-11-02
40370	SUPPL	2016-02-18
32536	SUPPL	2016-02-18
40369	SUPPL	2015-09-23
32535	SUPPL	2015-09-16
40368	SUPPL	2015-05-04
32534	SUPPL	2015-05-04
19540	SUPPL	2015-03-05
10315	SUPPL	2015-03-03
22949	ORIG	2013-06-10
19539	ORIG	2013-05-14
32533	ORIG	2013-05-13