Application 210595

Type: NDA
Sponsor: CIRCASSIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUAKLIR PRESSAIR	ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE	POWDER, METERED;INHALATION	0.4MG/INH;0.012MG/INH	No	No

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
N210595-001	DUAKLIR PRESSAIR	ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		RLD	2019-03-29

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
N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24
N210595-001	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	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 216 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	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210595-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210595-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210595-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210595-001	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	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210595-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210595-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210595-001	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	N210595-001	NC	2022-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210595-001	NC	2022-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210595-001	NC	2022-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210595-001	NC	2022-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210595-001	NC	2022-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210595-001	NC	2022-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210595-001	NC	2022-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210595-001	NC	2022-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210595-001	NC	2022-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210595-001	NC	2022-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210595-001	NC	2022-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210595-001	NC	2022-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210595-001	NC	2022-03-29	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N210595-001	NC	2022-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210595-001	NC	2022-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210595-001	NC	2022-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210595-001	NC	2022-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210595-001	NC	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
DUAKLIR PRESSAIR	ACLIDINIUM BROMIDE AND FORMOTEROL FUMARATE	Covis Pharma US, Inc	2eba3089-28b4-4190-9fba-2511246cfd16	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210595 application number: NDA210595

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-0900	DUAKLIR PRESSAIR	aclidinium bromide and formoterol fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
72124-001	DUAKLIR PRESSAIR	aclidinium bromide and formoterol fumarte	Circassia Pharmaceuticals Inc.	NDA	Current
72124-001	DUAKLIR PRESSAIR	aclidinium bromide and formoterol fumarte	Circassia Pharmaceuticals Inc.	NDA	Current
72124-001	DUAKLIR PRESSAIR	aclidinium bromide and formoterol fumarte	Circassia Pharmaceuticals Inc.	NDA	Current
72124-001	DUAKLIR PRESSAIR	aclidinium bromide and formoterol fumarte	Circassia Pharmaceuticals Inc.	NDA	Current
72124-001	DUAKLIR PRESSAIR	aclidinium bromide and formoterol fumarte	Circassia Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60579	ORIG	2019-10-17
58160	ORIG	2019-04-01
58141	ORIG	2019-03-29