Application 205382

Type: NDA
Sponsor: GLAXO GRP ENGLAND

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INCRUSE ELLIPTA	UMECLIDINIUM BROMIDE	POWDER;INHALATION	EQ 62.5MCG BASE/INH	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N205382-001	INCRUSE ELLIPTA	UMECLIDINIUM BROMIDE	EQ 0.0625MG BASE/INH	POWDER / INHALATION		RLD, RS	2014-04-30

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205382-001	INCRUSE ELLIPTA	EQ 0.0625MG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205382-001	INCRUSE ELLIPTA	EQ 62.5MCG BASE/INH	POWDER / INHALATION	RLD, RS	2014-04-30	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 346 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205382-001	7498440	2025-04-27		Drug substance, Drug product	2014-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205382-001	8309572	2025-04-27	U-1476		2014-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205382-001	8183257	2025-07-27	U-1476		2014-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205382-001	7498440	2025-04-27		Drug substance, Drug product	2014-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205382-001	8309572	2025-04-27	U-1476		2014-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205382-001	8183257	2025-07-27	U-1476		2014-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205382-001	7498440	2025-04-27		Drug substance, Drug product	2014-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205382-001	8309572	2025-04-27	U-1476		2014-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205382-001	8183257	2025-07-27	U-1476		2014-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205382-001	9333310	2027-10-02		Drug product	2016-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205382-001	8201556	2029-02-05		Drug product	2014-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205382-001	8746242	2030-10-11		Drug product	2014-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205382-001	7498440	2025-04-27		Drug substance, Drug product	2014-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205382-001	8309572	2025-04-27	U-1476		2014-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205382-001	8183257	2025-07-27	U-1476		2014-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205382-001	9333310	2027-10-02		Drug product	2016-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205382-001	8201556	2029-02-05		Drug product	2014-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205382-001	8746242	2030-10-11		Drug product	2014-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205382-001	7498440	2025-04-27		Drug substance, Drug product	2014-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205382-001	8309572	2025-04-27	U-1476		2014-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205382-001	8183257	2025-07-27	U-1476		2014-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205382-001	9333310	2027-10-02		Drug product	2016-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205382-001	8201556	2029-02-05		Drug product	2014-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205382-001	8746242	2030-10-11		Drug product	2014-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205382-001	7498440	2025-04-27		Drug substance, Drug product	2014-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205382-001	8309572	2025-04-27	U-1476		2014-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205382-001	8183257	2025-07-27	U-1476		2014-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205382-001	9333310	2027-10-02		Drug product	2016-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205382-001	7488827	2027-12-18		Drug substance, Drug product	2014-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205382-001	8201556	2029-02-05		Drug product	2014-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205382-001	8746242	2030-10-11		Drug product	2014-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205382-001	7498440	2025-04-27		Drug substance, Drug product	2014-05-21	`5bbf6a4d5a75…`

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	N205382-001	M-245	2022-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205382-001	M-245	2022-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205382-001	M-245	2022-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205382-001	M-172	2019-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205382-001	M-245	2022-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205382-001	M-245	2022-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205382-001	M-245	2022-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205382-001	M-245	2022-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205382-001	M-245	2022-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205382-001	M-245	2022-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205382-001	M-172	2019-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205382-001	M-172	2019-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205382-001	M-172	2019-02-24	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N205382-001	M-245	2022-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205382-001	M-245	2022-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205382-001	M-245	2022-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205382-001	M-245	2022-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205382-001	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 Ellipta	UMECLIDINIUM	Prasco Laboratories	763388a5-cc89-4c25-8562-521df679b7e8	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205382 application number: NDA205382
Incruse Ellipta	UMECLIDINIUM	GlaxoSmithKline LLC	dbb64747-1505-49d7-9a33-99dd402e96d3	2023-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205382 application number: NDA205382 ndc (product): 0173-0873

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0873	Incruse Ellipta	umeclidinium	GlaxoSmithKline LLC	NDA	Current
0173-0873	Incruse Ellipta	umeclidinium	GlaxoSmithKline LLC	NDA	Current
0173-0873	Incruse Ellipta	umeclidinium	GlaxoSmithKline LLC	NDA	Current
0173-0873	Incruse Ellipta	umeclidinium	GlaxoSmithKline LLC	NDA	Current
0173-0873	Incruse Ellipta	umeclidinium	GlaxoSmithKline LLC	NDA	Current
0173-0873	Incruse Ellipta	umeclidinium	GlaxoSmithKline LLC	NDA	Current
0173-0873	Incruse Ellipta	umeclidinium	GlaxoSmithKline LLC	NDA	Current
0173-0873	Incruse Ellipta	umeclidinium	GlaxoSmithKline LLC	NDA	Current
0173-0873	Incruse Ellipta	umeclidinium	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76823	SUPPL	2023-12-14
76796	SUPPL	2023-12-14
58997	SUPPL	2019-06-07
58994	SUPPL	2019-06-07
50167	SUPPL	2017-10-24
50131	SUPPL	2017-10-23
48751	SUPPL	2017-06-16
48714	SUPPL	2017-06-14
32664	SUPPL	2016-02-26
19638	SUPPL	2016-02-26
44917	ORIG	2015-08-11
22984	ORIG	2015-08-11
19637	ORIG	2014-05-02
10440	ORIG	2014-05-01