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 1.

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2020-07-23	`a50c72e98297…`
2026-08-01 22:54:32	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-001	8324266	2030-05-28	U-2889		2020-08-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-001	8703806	2030-05-28	U-2889		2020-08-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-001	9415009	2030-05-28	U-2889		2020-08-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-001	9463161	2030-05-28	U-2889	Drug product	2020-08-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-001	8815258	2031-03-17	U-2889		2020-08-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-001	11331442	2038-10-05		Drug product	2022-06-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-001	11833292	2038-10-05		Drug product	2023-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-002	10716753	2030-05-28	U-4503	Drug product	2026-05-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-002	8324266	2030-05-28	U-4503		2026-05-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-002	8703806	2030-05-28	U-4503		2026-05-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-002	8808713	2030-05-28	U-4503	Drug product	2026-05-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-002	9415009	2030-05-28	U-4503		2026-05-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-002	9463161	2030-05-28	U-4503	Drug product	2026-05-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-002	8815258	2031-03-17	U-4503		2026-05-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-002	11331442	2038-10-05		Drug product	2026-05-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212122-002	11833292	2038-10-05		Drug product	2026-05-19	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N212122-002	NS	2029-04-27	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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