Application 202450

Type: NDA
Sponsor: CIRCASSIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TUDORZA PRESSAIR	ACLIDINIUM BROMIDE	POWDER, METERED;INHALATION	0.4MG/INH	Yes	Yes

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

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
N202450-001	TUDORZA PRESSAIR	ACLIDINIUM BROMIDE	0.4MG/INH	POWDER, METERED / INHALATION		RLD, RS	2012-07-23

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26
N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 204 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	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`d06236e962d9…`

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	N202450-001	M-256	2022-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202450-001	M-256	2022-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202450-001	M-256	2022-03-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202450-001	M-256	2022-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202450-001	M-256	2022-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202450-001	M-256	2022-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202450-001	M-256	2022-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202450-001	M-256	2022-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202450-001	M-256	2022-03-29	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	N202450-001	M-256	2022-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202450-001	M-256	2022-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202450-001	M-256	2022-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202450-001	M-256	2022-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202450-001	M-256	2022-03-29	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tudorza Pressair	ACLIDINIUM BROMIDE	Covis Pharma US, Inc	6f92cceb-a63f-4470-99b6-56179d98f10f	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202450 application number: NDA202450

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-0800	Tudorza Pressair	aclidinium bromide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0800	Tudorza Pressair	aclidinium bromide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0800	Tudorza Pressair	aclidinium bromide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0800	Tudorza Pressair	aclidinium bromide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0800	Tudorza Pressair	aclidinium bromide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0800	Tudorza Pressair	aclidinium bromide	AstraZeneca Pharmaceutica	NDA	Current
0310-0800	Tudorza Pressair	aclidinium bromide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0800	Tudorza Pressair	aclidinium bromide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0800	Tudorza Pressair	aclidinium bromide	AstraZeneca Pharmaceuticals LP	NDA	Current
72124-002	Tudorza Pressair	aclidinium bromide	Circassia Pharmaceuticals Inc.	NDA	Current
72124-002	Tudorza Pressair	aclidinium bromide	Circassia Pharmaceuticals Inc.	NDA	Current
72124-002	Tudorza Pressair	aclidinium bromide	Circassia Pharmaceuticals Inc.	NDA	Current
72124-002	Tudorza Pressair	aclidinium bromide	Circassia Pharmaceuticals Inc.	NDA	Current
72124-002	Tudorza Pressair	aclidinium bromide	Circassia Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58158	SUPPL	2019-04-01
58142	SUPPL	2019-03-29
56469	SUPPL	2018-11-15
56417	SUPPL	2018-11-13
32264	SUPPL	2016-03-18
40186	SUPPL	2016-03-17
19352	SUPPL	2015-04-07
32263	SUPPL	2015-04-06
10054	SUPPL	2014-11-03
19351	SUPPL	2014-07-22
10053	SUPPL	2014-07-21
43403	ORIG	2012-09-05
24418	ORIG	2012-09-05
10052	ORIG	2012-07-25
19350	ORIG	2012-07-24