Application 212122

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BREZTRI AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	AEROSOL, METERED;INHALATION	160MCG/INH; 4.8 MCG/INH; 9MCG/INH	Yes	No
002	BREZTRI AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	AEROSOL, METERED;INHALATION	0.16MG/INH;0.0048MG/INH;0.018MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212122-001	BREZTRI AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2020-07-23
N212122-002	BREZTRI AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	0.16MG/INH;0.0048MG/INH;0.018MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2026-04-27

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18
N212122-001	8324266	2030-05-28	U-2889		2020-08-18
N212122-001	8703806	2030-05-28	U-2889		2020-08-18
N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18
N212122-001	9415009	2030-05-28	U-2889		2020-08-18
N212122-001	9463161	2030-05-28	U-2889	Drug product	2020-08-18
N212122-001	8815258	2031-03-17	U-2889		2020-08-18
N212122-001	11331442	2038-10-05		Drug product	2022-06-16
N212122-001	11833292	2038-10-05		Drug product	2023-12-21
N212122-002	10716753	2030-05-28	U-4503	Drug product	2026-05-19
N212122-002	8324266	2030-05-28	U-4503		2026-05-19
N212122-002	8703806	2030-05-28	U-4503		2026-05-19
N212122-002	8808713	2030-05-28	U-4503	Drug product	2026-05-19
N212122-002	9415009	2030-05-28	U-4503		2026-05-19
N212122-002	9463161	2030-05-28	U-4503	Drug product	2026-05-19
N212122-002	8815258	2031-03-17	U-4503		2026-05-19
N212122-002	11331442	2038-10-05		Drug product	2026-05-19
N212122-002	11833292	2038-10-05		Drug product	2026-05-19

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212122-002	NS	2029-04-27

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.

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	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.018MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2026-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212122-002	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.018MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2026-04-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 331 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	N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	8324266	2030-05-28	U-2889		2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	8703806	2030-05-28	U-2889		2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	9415009	2030-05-28	U-2889		2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	9463161	2030-05-28	U-2889	Drug product	2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	8815258	2031-03-17	U-2889		2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	11331442	2038-10-05		Drug product	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	11833292	2038-10-05		Drug product	2023-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	10716753	2030-05-28	U-4503	Drug product	2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	8324266	2030-05-28	U-4503		2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	8703806	2030-05-28	U-4503		2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	8808713	2030-05-28	U-4503	Drug product	2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	9415009	2030-05-28	U-4503		2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	9463161	2030-05-28	U-4503	Drug product	2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	8815258	2031-03-17	U-4503		2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	11331442	2038-10-05		Drug product	2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	11833292	2038-10-05		Drug product	2026-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	8324266	2030-05-28	U-2889		2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	8703806	2030-05-28	U-2889		2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	9415009	2030-05-28	U-2889		2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	9463161	2030-05-28	U-2889	Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	8815258	2031-03-17	U-2889		2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	11331442	2038-10-05		Drug product	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	11833292	2038-10-05		Drug product	2023-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	8324266	2030-05-28	U-2889		2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	8703806	2030-05-28	U-2889		2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	9415009	2030-05-28	U-2889		2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	9463161	2030-05-28	U-2889	Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	8815258	2031-03-17	U-2889		2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	11331442	2038-10-05		Drug product	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	11833292	2038-10-05		Drug product	2023-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212122-001	8324266	2030-05-28	U-2889		2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212122-001	8703806	2030-05-28	U-2889		2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N212122-002	NS	2029-04-27	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212122-001	NC	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212122-001	NC	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212122-001	NC	2023-07-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212122-001	NC	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212122-001	NC	2023-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212122-001	NC	2023-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212122-001	NC	2023-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212122-001	NC	2023-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212122-001	NC	2023-07-23	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N212122-001	NC	2023-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212122-001	NC	2023-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212122-001	NC	2023-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212122-001	NC	2023-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212122-001	NC	2023-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212122-001	NC	2023-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212122-001	NC	2023-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212122-001	NC	2023-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212122-001	NC	2023-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212122-001	NC	2023-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212122-001	NC	2023-07-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212122-002	NS	2029-04-27	`a50c72e98297…`

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
BREZTRI	BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE	AstraZeneca Pharmaceuticals LP	715433dc-cb2b-43ea-b6df-c5b4177adc6c	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212122 application number: NDA212122 ndc (product): 0310-4616

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-4616	BREZTRI	budesonide, glycopyrrolate, and formoterol fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-4616	BREZTRI	budesonide, glycopyrrolate, and formoterol fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-4616	BRETZRI	budesonide, glycopyrrolate, and formoterol fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85788	SUPPL	2026-05-01
85787	SUPPL	2026-05-01
73957	SUPPL	2023-04-06
68008	ORIG	2021-07-01
64099	ORIG	2020-07-27
64091	ORIG	2020-07-24