Application 202049

Type: NDA
Sponsor: CHIESI USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRONCHITOL	MANNITOL	POWDER;INHALATION	400MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N202049-001	BRONCHITOL	MANNITOL	40MG	POWDER / INHALATION		RLD, RS	2020-10-30

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202049-001	ODE-327	2027-10-30

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	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202049-001	BRONCHITOL	40MG	POWDER / INHALATION	RLD, RS	2020-10-30	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N202049-001	ODE-327	2027-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202049-001	ODE-327	2027-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202049-001	ODE-327	2027-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202049-001	ODE-327	2027-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202049-001	ODE-327	2027-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202049-001	ODE-327	2027-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202049-001	ODE-327	2027-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202049-001	ODE-327	2027-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202049-001	ODE-327	2027-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202049-001	ODE-327	2027-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202049-001	ODE-327	2027-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202049-001	ODE-327	2027-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202049-001	ODE-327	2027-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202049-001	ODE-327	2027-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202049-001	ODE-327	2027-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202049-001	NP	2023-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202049-001	ODE-327	2027-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202049-001	NP	2023-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202049-001	ODE-327	2027-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202049-001	NP	2023-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202049-001	ODE-327	2027-10-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202049-001	NP	2023-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202049-001	ODE-327	2027-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202049-001	NP	2023-10-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202049-001	ODE-327	2027-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202049-001	NP	2023-10-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202049-001	ODE-327	2027-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202049-001	NP	2023-10-30	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202049-001	ODE-327	2027-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202049-001	ODE-327	2027-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202049-001	NP	2023-10-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N202049-001	ODE-327	2027-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202049-001	NP	2023-10-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202049-001	ODE-327	2027-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202049-001	NP	2023-10-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202049-001	ODE-327	2027-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202049-001	NP	2023-10-30	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202049-001	ODE-327	2027-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202049-001	NP	2023-10-30	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202049-001	ODE-327	2027-10-30	`3f0d92c62455…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aridol Bronchial Challenge Test Kit	MANNITOL	Methapharm, Inc.	5387a4fb-b894-4cba-88a3-a947217d34da	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	Hospira, Inc.	8ad3145e-00e7-4412-b9a5-06f00f264f30	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	ProPharma Distribution	430669d7-9ad1-9a04-e063-6394a90ababb	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	ICU Medical Inc.	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Osmitrol	MANNITOL	Baxter Healthcare Company	0d914965-7001-45cb-ba51-d7c5964b05bc	2025-08-26	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	Henry Schein, Inc.	e2444db1-9dfe-451f-a33c-9b00786464d2	2025-05-20	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
MANNITOL	MANNITOL	HF Acquisition Co LLC, DBA HealthFirst	999ce711-2d5b-0d7d-e053-2995a90a2689	2024-01-27	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	B. Braun Medical Inc.	d12cc802-b538-4065-a264-f474ff3b3043	2023-08-15	Warnings, Adverse reactions	Name fallback generic name: MANNITOL
Mannitol	MANNITOL	Fresenius Kabi USA, LLC	c395e13d-6ea1-4104-8b37-669cfb982f04	2023-03-16	Warnings, Adverse reactions	Name fallback generic name: MANNITOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10122-212	Bronchitol	mannitol	Chiesi USA, Inc.	NDA	Current
10122-212	Bronchitol	mannitol	Chiesi USA, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68714	ORIG	2021-09-22
65131	ORIG	2020-11-03
65088	ORIG	2020-10-30