Application 209482

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRELEGY ELLIPTA	FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	POWDER;INHALATION	0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	Yes	Yes
002	TRELEGY ELLIPTA	FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	POWDER;INHALATION	0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209482-001	TRELEGY ELLIPTA	FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION		RLD, RS	2017-09-18
N209482-002	TRELEGY ELLIPTA	FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION		RLD, RS	2020-09-09

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209482-001	7488827	2027-12-18		Drug substance, Drug product	2017-10-06
N209482-001	8534281	2030-03-08		Drug product	2017-10-06
N209482-001	8534281*PED	2030-09-08		Pediatric extension
N209482-001	8746242	2030-10-11		Drug product	2017-10-06
N209482-001	11090294	2030-11-29	U-3202		2021-09-14
N209482-001	12396986	2030-11-29		Drug product	2025-09-18
N209482-001	9750726	2030-11-29		Drug product	2017-10-06
N209482-001	8746242*PED	2031-04-11		Pediatric extension
N209482-002	7488827	2027-12-18		Drug substance, Drug product	2020-10-06
N209482-002	8534281	2030-03-08		Drug product	2020-10-06
N209482-002	8534281*PED	2030-09-08		Pediatric extension
N209482-002	8746242	2030-10-11		Drug product	2020-10-06
N209482-002	12396986	2030-11-29		Drug product	2025-09-18
N209482-002	9750726	2030-11-29		Drug product	2020-10-06
N209482-002	8746242*PED	2031-04-11		Pediatric extension

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 3 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209482-001	TRELEGY ELLIPTA	0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-09-18	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209482-002	TRELEGY ELLIPTA	0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2020-09-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209482-001	TRELEGY ELLIPTA	0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2017-09-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209482-002	TRELEGY ELLIPTA	0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2020-09-09	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 35 · 1,376 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209482-001	7488827	2027-12-18		Drug substance, Drug product	2017-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-001	8534281	2030-03-08		Drug product	2017-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-001	8534281*PED	2030-09-08		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-001	8746242	2030-10-11		Drug product	2017-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-001	11090294	2030-11-29	U-3202		2021-09-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-001	12396986	2030-11-29		Drug product	2025-09-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-001	9750726	2030-11-29		Drug product	2017-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-001	8746242*PED	2031-04-11		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-002	7488827	2027-12-18		Drug substance, Drug product	2020-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-002	8534281	2030-03-08		Drug product	2020-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-002	8534281*PED	2030-09-08		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-002	8746242	2030-10-11		Drug product	2020-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-002	12396986	2030-11-29		Drug product	2025-09-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-002	9750726	2030-11-29		Drug product	2020-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209482-002	8746242*PED	2031-04-11		Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209482-001	7488827	2027-12-18		Drug substance, Drug product	2017-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-001	8534281	2030-03-08		Drug product	2017-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-001	8534281*PED	2030-09-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-001	8746242	2030-10-11		Drug product	2017-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-001	11090294	2030-11-29	U-3202		2021-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-001	12396986	2030-11-29		Drug product	2025-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-001	9750726	2030-11-29		Drug product	2017-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-001	8746242*PED	2031-04-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-002	7488827	2027-12-18		Drug substance, Drug product	2020-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-002	8534281	2030-03-08		Drug product	2020-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-002	8534281*PED	2030-09-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-002	8746242	2030-10-11		Drug product	2020-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-002	12396986	2030-11-29		Drug product	2025-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-002	9750726	2030-11-29		Drug product	2020-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209482-002	8746242*PED	2031-04-11		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209482-001	7488827	2027-12-18		Drug substance, Drug product	2017-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209482-001	8534281	2030-03-08		Drug product	2017-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209482-001	8534281*PED	2030-09-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209482-001	8746242	2030-10-11		Drug product	2017-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209482-001	11090294	2030-11-29	U-3202		2021-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209482-001	12396986	2030-11-29		Drug product	2025-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209482-001	9750726	2030-11-29		Drug product	2017-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209482-001	8746242*PED	2031-04-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209482-002	7488827	2027-12-18		Drug substance, Drug product	2020-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209482-002	8534281	2030-03-08		Drug product	2020-10-06	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 47 observed states.

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	N209482-001	I-843	2023-09-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209482-002	NS	2023-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209482-001	I-843	2023-09-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209482-002	NS	2023-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209482-001	I-843	2023-09-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209482-002	NS	2023-09-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209482-001	I-775	2021-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209482-001	I-843	2023-09-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209482-002	NS	2023-09-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209482-001	I-775	2021-04-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209482-001	I-843	2023-09-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209482-002	NS	2023-09-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209482-001	I-775	2021-04-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209482-001	I-843	2023-09-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209482-002	NS	2023-09-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209482-001	I-775	2021-04-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209482-001	I-843	2023-09-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209482-002	NS	2023-09-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209482-001	I-775	2021-04-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209482-001	I-843	2023-09-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209482-002	NS	2023-09-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209482-001	I-775	2021-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209482-001	I-775	2021-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209482-001	I-775	2021-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209482-001	I-775	2021-04-24	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N209482-001	I-843	2023-09-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N209482-002	NS	2023-09-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209482-001	I-843	2023-09-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209482-002	NS	2023-09-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209482-001	I-843	2023-09-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209482-002	NS	2023-09-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209482-001	I-843	2023-09-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209482-002	NS	2023-09-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209482-001	I-843	2023-09-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209482-002	NS	2023-09-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209482-001	I-843	2023-09-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N209482-002	NS	2023-09-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209482-001	I-843	2023-09-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N209482-002	NS	2023-09-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209482-001	I-843	2023-09-09	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trelegy Ellipta	FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE	GlaxoSmithKline LLC	b5a81d5a-4648-4c7a-951d-33c014a63c7e	2023-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209482 application number: NDA209482 ndc (product): 0173-0887 ndc (product): 0173-0893

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0887	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0887	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0887	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0887	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0887	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0887	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0887	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0893	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0893	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0893	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current
0173-0893	Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74433	SUPPL	2023-06-05
74426	SUPPL	2023-06-05
72793	SUPPL	2022-12-05
72787	SUPPL	2022-12-05
71060	SUPPL	2022-05-12
71057	SUPPL	2022-05-12
64550	SUPPL	2020-09-10
64549	SUPPL	2020-09-10
64547	SUPPL	2020-09-10
64546	SUPPL	2020-09-10
58757	SUPPL	2019-05-16
58749	SUPPL	2019-05-16
57543	SUPPL	2019-02-13
57140	SUPPL	2019-01-08
57127	SUPPL	2019-01-08
53814	SUPPL	2018-04-24
53803	SUPPL	2018-04-24
52674	ORIG	2018-02-20
49847	ORIG	2017-09-22
49812	ORIG	2017-09-20
49811	ORIG	2017-09-20