Application 212535

Type: NDA
Sponsor: AVADEL LEGACY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOURESS	CYSTEINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	500MG/10ML (50MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N212535-001	NOURESS	CYSTEINE HYDROCHLORIDE	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2019-12-13

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212535-001	10478453	2039-01-15	U-2752	Drug product	2020-07-28
N212535-001	10583155	2039-01-15	U-2752	Drug product	2020-07-28
N212535-001	10653719	2039-01-15		Drug product	2020-07-28
N212535-001	10905713	2039-01-15		Drug product	2021-03-04
N212535-001	10905714	2039-01-15		Drug product	2021-03-04
N212535-001	10912795	2039-01-15		Drug product	2021-03-04
N212535-001	10918662	2039-01-15		Drug product	2021-03-04
N212535-001	10933089	2039-01-15		Drug product	2021-03-29
N212535-001	11510942	2039-01-15	U-2752	Drug product	2023-03-24
N212535-001	11642370	2039-01-15		Drug product	2024-05-17
N212535-001	11648262	2039-01-15		Drug product	2024-05-17
N212535-001	11679125	2039-01-15		Drug product	2024-05-17
N212535-001	11684636	2039-01-15		Drug product	2024-05-17
N212535-001	11826383	2039-01-15		Drug product	2024-05-17
N212535-001	12569514	2039-01-15		Drug product	2026-06-25
N212535-001	11510941	2039-03-02		Drug product	2023-03-24
N212535-001	10493051	2039-03-15		Drug product	2020-01-29
N212535-001	10543186	2039-03-15	U-2722		2020-01-29
N212535-001	10702490	2039-03-15		Drug product	2020-08-04
N212535-001	11045438	2039-03-15		Drug product	2021-08-05

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
2026-02-19 14:30 UTC	2026-02	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212535-001	NOURESS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-12-13	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 542 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212535-001	10478453	2039-01-15	U-2752	Drug product	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10583155	2039-01-15	U-2752	Drug product	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10653719	2039-01-15		Drug product	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10905713	2039-01-15		Drug product	2021-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10905714	2039-01-15		Drug product	2021-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10912795	2039-01-15		Drug product	2021-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10918662	2039-01-15		Drug product	2021-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10933089	2039-01-15		Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	11510942	2039-01-15	U-2752	Drug product	2023-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	11642370	2039-01-15		Drug product	2024-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	11648262	2039-01-15		Drug product	2024-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	11679125	2039-01-15		Drug product	2024-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	11684636	2039-01-15		Drug product	2024-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	11826383	2039-01-15		Drug product	2024-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	11510941	2039-03-02		Drug product	2023-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10493051	2039-03-15		Drug product	2020-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10543186	2039-03-15	U-2722		2020-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	10702490	2039-03-15		Drug product	2020-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212535-001	11045438	2039-03-15		Drug product	2021-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10478453	2039-01-15	U-2752	Drug product	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10583155	2039-01-15	U-2752	Drug product	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10653719	2039-01-15		Drug product	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10905713	2039-01-15		Drug product	2021-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10905714	2039-01-15		Drug product	2021-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10912795	2039-01-15		Drug product	2021-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10918662	2039-01-15		Drug product	2021-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10933089	2039-01-15		Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	11510942	2039-01-15	U-2752	Drug product	2023-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	11642370	2039-01-15		Drug product	2024-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	11648262	2039-01-15		Drug product	2024-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	11679125	2039-01-15		Drug product	2024-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	11684636	2039-01-15		Drug product	2024-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	11826383	2039-01-15		Drug product	2024-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	11510941	2039-03-02		Drug product	2023-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10493051	2039-03-15		Drug product	2020-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10543186	2039-03-15	U-2722		2020-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	10702490	2039-03-15		Drug product	2020-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212535-001	11045438	2039-03-15		Drug product	2021-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212535-001	10478453	2039-01-15	U-2752	Drug product	2020-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212535-001	10583155	2039-01-15	U-2752	Drug product	2020-07-28	`6a471c1ec25d…`

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
CYSTEINE HYDROCHLORIDE	CYSTEINE HYDROCHLORIDE	Baxter Healthcare Corporation	cbf70fc3-14b3-4c17-8de8-acba1e12ac95	2022-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212535 application number: NDA212535 ndc (product): 0338-9645

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
0338-9645	CYSTEINE HYDROCHLORIDE	cysteine hydrochloride	Baxter Healthcare Corporation	NDA	Current
76014-006	Nouress	cysteine hydrochloride	Avadel Legacy Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62149	ORIG	2020-03-16
61295	ORIG	2019-12-17
61276	ORIG	2019-12-16