Application 210660

Type: NDA
Sponsor: EXELA PHARMA SCS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELCYS	CYSTEINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	500MG/10ML (50MG/ML)	Yes	Yes
002	ELCYS	CYSTEINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	2500MG/50ML (50MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N210660-001	ELCYS	CYSTEINE HYDROCHLORIDE	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16
N210660-002	ELCYS	CYSTEINE HYDROCHLORIDE	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-12-04

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210660-001	10478453	2039-01-15	U-2752	Drug product	2019-11-19
N210660-001	10583155	2039-01-15	U-2752	Drug product	2020-03-10
N210660-001	10653719	2039-01-15		Drug product	2020-07-02
N210660-001	10905713	2039-01-15		Drug product	2021-02-02
N210660-001	10905714	2039-01-15		Drug product	2021-02-02
N210660-001	10912795	2039-01-15		Drug product	2021-02-09
N210660-001	10918662	2039-01-15		Drug product	2021-02-16
N210660-001	10933089	2039-01-15		Drug product	2021-03-02
N210660-001	11510941	2039-01-15		Drug product	2022-12-06
N210660-001	11510942	2039-01-15	U-2752	Drug product	2022-12-06
N210660-001	11642370	2039-01-15		Drug product	2023-06-06
N210660-001	11648262	2039-01-15		Drug product	2023-06-06
N210660-001	11679125	2039-01-15		Drug product	2023-06-23
N210660-001	11684636	2039-01-15		Drug product	2023-07-03
N210660-001	11826383	2039-01-15		Drug product	2023-12-06
N210660-001	11969439	2039-01-15	U-2752		2024-05-29

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 2 of 2 · 64 observed 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
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210660-001	AP	1	`5c6f7cd8ea54…`
2022-09-29 23:25 UTC	2022-09	N210660-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210660-001	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 499 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210660-001	10478453	2039-01-15	U-2752	Drug product	2019-11-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	10583155	2039-01-15	U-2752	Drug product	2020-03-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	10653719	2039-01-15		Drug product	2020-07-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	10905713	2039-01-15		Drug product	2021-02-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	10905714	2039-01-15		Drug product	2021-02-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	10912795	2039-01-15		Drug product	2021-02-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	10918662	2039-01-15		Drug product	2021-02-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	10933089	2039-01-15		Drug product	2021-03-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	11510941	2039-01-15		Drug product	2022-12-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	11510942	2039-01-15	U-2752	Drug product	2022-12-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	11642370	2039-01-15		Drug product	2023-06-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	11648262	2039-01-15		Drug product	2023-06-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	11679125	2039-01-15		Drug product	2023-06-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	11684636	2039-01-15		Drug product	2023-07-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	11826383	2039-01-15		Drug product	2023-12-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210660-001	11969439	2039-01-15	U-2752		2024-05-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210660-001	10478453	2039-01-15	U-2752	Drug product	2019-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10583155	2039-01-15	U-2752	Drug product	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10653719	2039-01-15		Drug product	2020-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10905713	2039-01-15		Drug product	2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10905714	2039-01-15		Drug product	2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10912795	2039-01-15		Drug product	2021-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10918662	2039-01-15		Drug product	2021-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10933089	2039-01-15		Drug product	2021-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11510941	2039-01-15		Drug product	2022-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11510942	2039-01-15	U-2752	Drug product	2022-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11642370	2039-01-15		Drug product	2023-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11648262	2039-01-15		Drug product	2023-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11679125	2039-01-15		Drug product	2023-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11684636	2039-01-15		Drug product	2023-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11826383	2039-01-15		Drug product	2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11969439	2039-01-15	U-2752		2024-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210660-001	10478453	2039-01-15	U-2752	Drug product	2019-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10583155	2039-01-15	U-2752	Drug product	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10653719	2039-01-15		Drug product	2020-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10905713	2039-01-15		Drug product	2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10905714	2039-01-15		Drug product	2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10912795	2039-01-15		Drug product	2021-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10918662	2039-01-15		Drug product	2021-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10933089	2039-01-15		Drug product	2021-03-02	`caaa826d4ba7…`

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
ELCYS	CYSTEINE HYDROCHLORIDE	Exela Pharma Sciences, LLC	52317b38-b2e6-4a1c-b5b0-43cada0d205e	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210660 application number: NDA210660
ELCYS	CYSTEINE HYDROCHLORIDE	Exela Pharma Sciences, LLC	e7652275-1c53-490c-82ad-e63867df5788	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210660 application number: NDA210660 ndc (product): 51754-1007

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-1007	ELCYS	Cysteine Hydrochloride	Exela Pharma Sciences, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77118	SUPPL	2023-12-22
77108	SUPPL	2023-12-22
61148	ORIG	2019-12-04
58366	ORIG	2019-04-22
58386	ORIG	2019-04-16