Application 209080

Type: NDA
Sponsor: ITALFARMACO SPA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIGLUTIK KIT	RILUZOLE	SUSPENSION;ORAL	50MG/10ML	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
N209080-001	TIGLUTIK KIT	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N209080-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL	AB	RLD, RS	2018-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209080-001	TIGLUTIK KIT	50MG/10ML	SUSPENSION / ORAL		RLD, RS	2018-09-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N209080-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209080-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209080-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209080-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209080-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209080-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209080-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209080-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209080-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209080-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209080-001	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209080-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 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	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209080-001	8765150	2029-03-12	U-2401	Drug product	2018-09-27	`e64feba35796…`

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
TIGLUTIK	RILUZOLE	Italfarmaco SPA	20b7165a-eb4d-42a0-b2d8-16eff90a214e	2026-07-29		Exact identifier application applno (NDA): 209080 application number: NDA209080
TIGLUTIK	RILUZOLE	EDW PHARMA, INC	75d68f19-4208-109e-e053-2991aa0ac857	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209080 application number: NDA209080 ndc (product): 70726-0303

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70726-0303	TIGLUTIK	Riluzole	Itf Pharma, Inc.	NDA	Current
70726-0303	TIGLUTIK	Riluzole	Itf Pharma, Inc.	NDA	Current
70726-0303	TIGLUTIK	Riluzole	Itf Pharma, Inc.	NDA	Current
70726-0303	TIGLUTIK	Riluzole	Itf Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83350	SUPPL	2025-09-12
83343	SUPPL	2025-09-12
62945	SUPPL	2020-05-13
62917	SUPPL	2020-05-12
61297	SUPPL	2019-12-17
61283	SUPPL	2019-12-16
57950	ORIG	2019-03-11
55452	ORIG	2018-09-12
55389	ORIG	2018-09-06