Application 203975

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANORO ELLIPTA	UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	POWDER;INHALATION	EQ 0.0625MG BASE/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203975-001	ANORO ELLIPTA	UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION		RLD, RS	2013-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09
N203975-001	8511304*PED	2027-12-14		Pediatric extension
N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09
N203975-001	11090294	2030-11-29	U-3203		2021-09-14
N203975-001	12396986	2030-11-29		Drug product	2025-09-19
N203975-001	9750726	2030-11-29		Drug product	2017-09-21

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 · 42 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	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 628 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	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	8511304*PED	2027-12-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	11090294	2030-11-29	U-3203		2021-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	12396986	2030-11-29		Drug product	2025-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	9750726	2030-11-29		Drug product	2017-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	8511304*PED	2027-12-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	11090294	2030-11-29	U-3203		2021-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	12396986	2030-11-29		Drug product	2025-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	9750726	2030-11-29		Drug product	2017-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	7498440	2025-04-27		Drug substance, Drug product	2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	8309572	2025-04-27	U-1476		2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	7439393	2025-05-21	U-1476	Drug substance, Drug product	2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	8183257	2025-07-27	U-1476			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	7439393*PED	2025-11-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	8511304*PED	2027-12-14		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	11090294	2030-11-29	U-3203		2021-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	12396986	2030-11-29		Drug product	2025-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	9750726	2030-11-29		Drug product	2017-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203975-001	7498440	2025-04-27		Drug substance, Drug product	2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	8309572	2025-04-27	U-1476		2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	7439393	2025-05-21	U-1476	Drug substance, Drug product	2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	8183257	2025-07-27	U-1476			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	7439393*PED	2025-11-21		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	8511304*PED	2027-12-14		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	11090294	2030-11-29	U-3203		2021-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	9750726	2030-11-29		Drug product	2017-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	7498440	2025-04-27		Drug substance, Drug product	2014-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	8309572	2025-04-27	U-1476		2014-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	7439393	2025-05-21	U-1476	Drug substance, Drug product	2014-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	8183257	2025-07-27	U-1476			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	7439393*PED	2025-11-21		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	9333310	2027-10-02		Drug product	2016-05-20	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203975-001	M-245	2022-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203975-001	M-245	2022-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203975-001	M-245	2022-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203975-001	M-245	2022-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203975-001	M-245	2022-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203975-001	M-245	2022-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203975-001	M-245	2022-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203975-001	M-245	2022-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203975-001	M-245	2022-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203975-001	M-245	2022-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203975-001	M-245	2022-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203975-001	M-245	2022-06-09	`b00525d2431f…`
2023-01-26 05:58 UTC	2023-01	N203975-001	M-245	2022-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203975-001	M-245	2022-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203975-001	M-245	2022-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203975-001	M-245	2022-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203975-001	M-245	2022-06-09	`cb3db0bc1861…`

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
Umeclidinium and Vilanterol Ellipta	UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE	Prasco Laboratories	6de414b1-f707-4b98-9e4b-742032ec90af	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203975 application number: NDA203975
Anoro Ellipta	UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE	GlaxoSmithKline LLC	2dbd0671-c565-40c5-bf0f-e324db26799c	2023-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203975 application number: NDA203975 ndc (product): 0173-0869

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0869	Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74431	SUPPL	2023-06-05
74430	SUPPL	2023-06-05
72447	SUPPL	2022-10-21
72443	SUPPL	2022-10-21
59172	SUPPL	2019-06-26
59169	SUPPL	2019-06-25
58947	SUPPL	2019-06-04
58887	SUPPL	2019-05-30
50118	SUPPL	2017-10-19
50099	SUPPL	2017-10-19
47680	SUPPL	2017-03-24
47657	SUPPL	2017-03-23
47656	SUPPL	2017-03-23
40333	SUPPL	2016-02-26
10262	SUPPL	2016-02-26
43449	ORIG	2014-01-06
24454	ORIG	2014-01-06
32484	ORIG	2013-12-20
40332	ORIG	2013-12-19