Application 219622

Type: NDA
Sponsor: CHIESI FARMACEUTICI SPA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIMBOW	BECLOMETHASONE DIPROPIONATE, FORMOTEROL FUMARATE, AND GLYCOPYRROLATE	AEROSOL;INHALATION	86MCG/4.9MCG/10.6MCG, 86MCG, 4.9MCG, 10.6MCG	No	No
002	TRIMBOW	BECLOMETHASONE DIPROPIONATE, FORMOTEROL FUMARATE, AND GLYCOPYRROLATE	AEROSOL;INHALATION	172MCG/4.9MCG/10.6MCG, 172MCG, 4.9MCG, 10.6MCG	No	No

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
N219622-001	TRIMBOW	BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	0.086MG/INH;0.0049MG/INH;0.0106MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2026-05-14
N219622-002	TRIMBOW	BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	0.172MG/INH;0.0049MG/INH;0.0106MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2026-05-14

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219622-001	10159645	2030-12-23	U-4538	Drug product	2026-06-05
N219622-001	10806701	2030-12-23		Drug product	2026-06-05
N219622-001	11389401	2030-12-23		Drug product	2026-06-05
N219622-001	11590074	2030-12-23	U-4538		2026-06-05
N219622-001	12357568	2030-12-23	U-4538	Drug product	2026-06-05
N219622-001	10617638	2034-12-23	U-4538	Drug product	2026-06-05
N219622-002	10159645	2030-12-23	U-4538	Drug product	2026-06-05
N219622-002	10806701	2030-12-23		Drug product	2026-06-05
N219622-002	11389401	2030-12-23		Drug product	2026-06-05
N219622-002	11590074	2030-12-23	U-4538		2026-06-05
N219622-002	12357568	2030-12-23	U-4538	Drug product	2026-06-05
N219622-002	10617638	2034-12-23	U-4538	Drug product	2026-06-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219622-001	NP	2029-05-14
N219622-002	NP	2029-05-14

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	N219622-001	TRIMBOW	0.086MG/INH;0.0049MG/INH;0.0106MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2026-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-002	TRIMBOW	0.172MG/INH;0.0049MG/INH;0.0106MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2026-05-14	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-001	TRIMBOW	0.086MG/INH;0.0049MG/INH;0.0106MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2026-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-002	TRIMBOW	0.172MG/INH;0.0049MG/INH;0.0106MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2026-05-14	`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
2026-08-18 06:07:40	2026-07	N219622-001	10159645	2030-12-23	U-4538	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-001	10806701	2030-12-23		Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-001	11389401	2030-12-23		Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-001	11590074	2030-12-23	U-4538		2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-001	12357568	2030-12-23	U-4538	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-001	10617638	2034-12-23	U-4538	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-002	10159645	2030-12-23	U-4538	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-002	10806701	2030-12-23		Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-002	11389401	2030-12-23		Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-002	11590074	2030-12-23	U-4538		2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-002	12357568	2030-12-23	U-4538	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-002	10617638	2034-12-23	U-4538	Drug product	2026-06-05	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-001	10159645	2030-12-23	U-4538	Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-001	10806701	2030-12-23		Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-001	11389401	2030-12-23		Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-001	11590074	2030-12-23	U-4538		2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-001	12357568	2030-12-23	U-4538	Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-001	10617638	2034-12-23	U-4538	Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-002	10159645	2030-12-23	U-4538	Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-002	10806701	2030-12-23		Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-002	11389401	2030-12-23		Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-002	11590074	2030-12-23	U-4538		2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-002	12357568	2030-12-23	U-4538	Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-002	10617638	2034-12-23	U-4538	Drug product	2026-06-05	`a50c72e98297…`

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	N219622-001	NP	2029-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219622-002	NP	2029-05-14	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-001	NP	2029-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219622-002	NP	2029-05-14	`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
Trimbow	BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE	Chiesi USA, Inc.	4e13e70f-f550-4603-bbfb-346f80df3c4f	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219622 application number: NDA219622

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85972	ORIG	2026-05-19
85954	ORIG	2026-05-18