Application 209184

Type: NDA
Sponsor: ACORDA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INBRIJA	LEVODOPA	POWDER;INHALATION	42MG	Yes	Yes

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
N209184-001	INBRIJA	LEVODOPA	42MG	POWDER / INHALATION		RLD, RS	2018-12-21

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209184-001	RE43711	2029-02-03	U-2484		2019-01-18
N209184-001	8545878	2032-11-16		Drug product	2019-01-18
N209184-001	8685442	2032-11-16		Drug product	2019-01-18
N209184-001	8945612	2032-11-16		Drug product	2019-01-18
N209184-001	9393210	2032-11-16		Drug product	2019-01-18
N209184-001	12458615	2033-10-21	U-2484		2025-11-26

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 1 of 2 · 42 observed 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	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209184-001	INBRIJA	42MG	POWDER / INHALATION	RLD, RS	2018-12-21	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 395 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	N209184-001	RE43711	2029-02-03	U-2484		2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209184-001	8545878	2032-11-16		Drug product	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209184-001	8685442	2032-11-16		Drug product	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209184-001	8945612	2032-11-16		Drug product	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209184-001	9393210	2032-11-16		Drug product	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209184-001	12458615	2033-10-21	U-2484		2025-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209184-001	RE43711	2029-02-03	U-2484		2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209184-001	8545878	2032-11-16		Drug product	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209184-001	8685442	2032-11-16		Drug product	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209184-001	8945612	2032-11-16		Drug product	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209184-001	9393210	2032-11-16		Drug product	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209184-001	12458615	2033-10-21	U-2484		2025-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209184-001	RE43711	2029-02-03	U-2484		2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209184-001	8545878	2032-11-16		Drug product	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209184-001	8685442	2032-11-16		Drug product	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209184-001	8945612	2032-11-16		Drug product	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209184-001	9393210	2032-11-16		Drug product	2019-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209184-001	RE43711	2029-02-03	U-2484		2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209184-001	8545878	2032-11-16		Drug product	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209184-001	8685442	2032-11-16		Drug product	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209184-001	8945612	2032-11-16		Drug product	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209184-001	9393210	2032-11-16		Drug product	2019-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209184-001	RE43711	2029-02-03	U-2484		2019-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209184-001	8545878	2032-11-16		Drug product	2019-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209184-001	8685442	2032-11-16		Drug product	2019-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209184-001	8945612	2032-11-16		Drug product	2019-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209184-001	9393210	2032-11-16		Drug product	2019-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209184-001	RE43711	2029-02-03	U-2484		2019-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209184-001	8545878	2032-11-16		Drug product	2019-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209184-001	8685442	2032-11-16		Drug product	2019-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209184-001	8945612	2032-11-16		Drug product	2019-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209184-001	9393210	2032-11-16		Drug product	2019-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209184-001	7182961	2024-02-22		Drug product	2019-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209184-001	RE43711	2029-02-03	U-2484		2019-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209184-001	8545878	2032-11-16		Drug product	2019-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209184-001	8685442	2032-11-16		Drug product	2019-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209184-001	8945612	2032-11-16		Drug product	2019-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209184-001	9393210	2032-11-16		Drug product	2019-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209184-001	7182961	2024-02-22		Drug product	2019-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209184-001	RE43711	2029-02-03	U-2484		2019-01-18	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209184-001	NP	2021-12-21	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209184-001	NP	2021-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209184-001	NP	2021-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209184-001	NP	2021-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209184-001	NP	2021-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209184-001	NP	2021-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209184-001	NP	2021-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209184-001	NP	2021-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209184-001	NP	2021-12-21	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Inbrija	LEVODOPA	Merz Pharmaceuticals, LLC	077c0f39-a3a2-4b2b-a184-09131889dcfb	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209184 application number: NDA209184
Inbrija	LEVODOPA	Merz Pharmaceuticals, LLC	a906f8e1-6e1c-480a-8276-c01bc65dd3be	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209184 application number: NDA209184 ndc (product): 10144-342

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
10144-342	Inbrija	levodopa	Acorda Therapeutics, Inc.	NDA	Current
10144-342	Inbrija	levodopa	Acorda Therapeutics, Inc.	NDA	Current
10144-342	Inbrija	levodopa	Acorda Therapeutics, Inc.	NDA	Current
10144-342	Inbrija	levodopa	Acorda Therapeutics, Inc.	NDA	Current
10144-342	Inbrija	levodopa	Acorda Therapeutics, Inc.	NDA	Current
10144-342	Inbrija	levodopa	Acorda Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85620	SUPPL	2026-04-02
85619	SUPPL	2026-04-02
64501	SUPPL	2020-09-04
64500	SUPPL	2020-09-04
64479	SUPPL	2020-09-02
64478	SUPPL	2020-09-02
59889	SUPPL	2019-08-30
58866	ORIG	2019-05-28
57064	ORIG	2018-12-30
57033	ORIG	2018-12-26