Application 205625

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARNUITY ELLIPTA	FLUTICASONE FUROATE	POWDER;INHALATION	0.1MG/INH	Yes	Yes
002	ARNUITY ELLIPTA	FLUTICASONE FUROATE	POWDER;INHALATION	0.2MG/INH	Yes	Yes
003	ARNUITY ELLIPTA	FLUTICASONE FUROATE	POWDER;INHALATION	0.05MG/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
N205625-001	ARNUITY ELLIPTA	FLUTICASONE FUROATE	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20
N205625-002	ARNUITY ELLIPTA	FLUTICASONE FUROATE	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20
N205625-003	ARNUITY ELLIPTA	FLUTICASONE FUROATE	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205625-003	M-290	2026-03-01

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 · 126 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	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205625-002	ARNUITY ELLIPTA	0.2MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205625-003	ARNUITY ELLIPTA	0.05MG/INH	POWDER / INHALATION	RLD, RS	2018-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205625-001	ARNUITY ELLIPTA	0.1MG/INH	POWDER / INHALATION	RLD, RS	2014-08-20	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 780 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-001	9333310	2027-10-02	Drug product	2016-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-001	9333310*PED	2028-04-02	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-001	8201556	2029-02-05	Drug product	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-001	8746242	2030-10-11	Drug product	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-001	8746242*PED	2031-04-11	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-002	9333310	2027-10-02	Drug product	2016-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-002	9333310*PED	2028-04-02	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-002	8201556	2029-02-05	Drug product	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-002	8746242	2030-10-11	Drug product	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-002	8746242*PED	2031-04-11	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-003	9333310	2027-10-02	Drug product	2018-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-003	9333310*PED	2028-04-02	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-003	8201556	2029-02-05	Drug product	2018-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-003	8746242	2030-10-11	Drug product	2018-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-003	8746242*PED	2031-04-11	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-001	9333310	2027-10-02	Drug product	2016-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-001	9333310*PED	2028-04-02	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-001	8201556	2029-02-05	Drug product	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-001	8746242	2030-10-11	Drug product	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-001	8746242*PED	2031-04-11	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-002	9333310	2027-10-02	Drug product	2016-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-002	9333310*PED	2028-04-02	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-002	8201556	2029-02-05	Drug product	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-002	8746242	2030-10-11	Drug product	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-002	8746242*PED	2031-04-11	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-003	9333310	2027-10-02	Drug product	2018-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-003	9333310*PED	2028-04-02	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-003	8201556	2029-02-05	Drug product	2018-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-003	8746242	2030-10-11	Drug product	2018-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-003	8746242*PED	2031-04-11	Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-001	9333310	2027-10-02	Drug product	2016-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-001	9333310*PED	2028-04-02	Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-001	8201556	2029-02-05	Drug product	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-001	8746242	2030-10-11	Drug product	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-001	8746242*PED	2031-04-11	Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-002	9333310	2027-10-02	Drug product	2016-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-002	9333310*PED	2028-04-02	Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-002	8201556	2029-02-05	Drug product	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-002	8746242	2030-10-11	Drug product	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-002	8746242*PED	2031-04-11	Pediatric extension		`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 41 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	N205625-003	M-290	2026-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205625-003	M-290	2026-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205625-003	M-290	2026-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205625-003	M-290	2026-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205625-003	M-290	2026-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205625-003	M-290	2026-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205625-003	M-290	2026-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205625-003	M-290	2026-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205625-003	M-290	2026-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205625-003	M-290	2026-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205625-003	M-290	2026-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205625-003	M-290	2026-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205625-003	M-290	2026-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205625-003	M-290	2026-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205625-003	M-290	2026-03-01	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N205625-001	NPP	2021-05-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205625-003	NS	2021-05-17	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N205625-001	NPP	2021-05-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205625-003	NS	2021-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205625-001	NPP	2021-05-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205625-003	NS	2021-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205625-001	NPP	2021-05-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205625-003	NS	2021-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205625-001	NPP	2021-05-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205625-003	NS	2021-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205625-001	NPP	2021-05-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205625-003	NS	2021-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205625-001	NPP	2021-05-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205625-003	NS	2021-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205625-001	NPP	2021-05-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205625-003	NS	2021-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205625-001	NPP	2021-05-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205625-003	NS	2021-05-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205625-003	M-290	2026-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205625-003	M-290	2026-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205625-003	M-290	2026-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205625-003	M-290	2026-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205625-003	M-290	2026-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205625-003	M-290	2026-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205625-003	M-290	2026-03-01	`3f0d92c62455…`

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 Ellipta	FLUTICASONE FUROATE	Prasco Laboratories	d3e797fc-2636-49a0-b89e-5246b18ee440	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205625 application number: NDA205625
Arnuity Ellipta	FLUTICASONE FUROATE	GlaxoSmithKline LLC	50f193ee-1691-486d-9370-a664df63695c	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205625 application number: NDA205625 ndc (product): 0173-0874 ndc (product): 0173-0876 ndc (product): 0173-0888

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0874	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0874	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0874	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0874	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0874	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0876	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0876	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0876	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0876	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0876	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0888	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0888	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0888	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0888	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current
0173-0888	Arnuity Ellipta	fluticasone furoate	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75863	SUPPL	2023-10-19
75845	SUPPL	2023-10-19
73656	SUPPL	2023-03-02
73652	SUPPL	2023-03-02
57541	SUPPL	2019-02-13
57128	SUPPL	2019-01-08
54267	SUPPL	2018-05-21
54260	SUPPL	2018-05-21
44927	ORIG	2015-10-07
43496	ORIG	2015-10-07
40486	SUPPL	2015-03-24
10479	SUPPL	2015-03-24
19668	ORIG	2014-08-22
10478	ORIG	2014-08-21
51112	ORIG	1900-01-01
51111	ORIG	1900-01-01
51110	ORIG	1900-01-01