Application 020599

Type: NDA
Sponsor: COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RILUTEK	RILUZOLE	TABLET;ORAL	50MG	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
N020599-001	RILUTEK	RILUZOLE	50MG	TABLET / ORAL		RLD	1995-12-12

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	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020599-001	RILUTEK	50MG	TABLET / ORAL		RLD	1995-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020599-001	RILUTEK	50MG	TABLET / ORAL	AB	RLD, RS	1995-12-12	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N020599-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020599-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020599-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020599-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020599-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020599-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020599-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020599-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020599-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020599-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020599-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020599-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020599-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020599-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020599-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020599-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020599-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020599-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020599-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020599-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020599-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020599-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020599-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020599-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020599-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020599-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020599-001	AB	1	`cb3db0bc1861…`

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 · 10 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		Name fallback generic name: RILUZOLE
TIGLUTIK	RILUZOLE	EDW PHARMA, INC	75d68f19-4208-109e-e053-2991aa0ac857	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: RILUZOLE
Riluzole	RILUZOLE	Ascend Laboratories, LLC	dd432c13-389e-46b3-8891-0cf1a58800ff	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: RILUZOLE
RILUZOLE	RILUZOLE	Florida Pharmaceutical Products, LLC	ccead445-970c-46a1-9532-2848cc2aa3b6	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: RILUZOLE
Riluzole	RILUZOLE	AvKARE	b117b981-476c-f9b8-e053-2995a90aee5f	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: RILUZOLE
Teglutik	RILUZOLE	EDW PHARMA	1a3aeb59-d589-8d12-e063-6394a90a0a3a	2025-12-31		Name fallback generic name: RILUZOLE
Teglutik	RILUZOLE	EDW PHARMA, INC	0f2b5cfc-a23d-699a-e063-6394a90a67d1	2025-12-31		Name fallback generic name: RILUZOLE
Teglutik	RILUZOLE	EDW PHARMA	125fdd37-02f7-a610-e063-6294a90a009d	2025-12-31		Name fallback generic name: RILUZOLE
riluzole	RILUZOLE	Glenmark Pharmaceuticals Inc., USA	f1ce57e8-d3fe-422c-8724-3101c258898a	2020-07-10	Warnings, Adverse reactions	Name fallback generic name: RILUZOLE
Riluzole	RILUZOLE	Sun Pharmaceutical Industries, Inc.	4c851be4-f0d0-4b24-baf9-427ddfc6f7b0	2020-05-16	Warnings, Adverse reactions	Name fallback generic name: RILUZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64980-191	Riluzole	riluzole	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
70515-700	Rilutek	riluzole	Covis Pharma	NDA	Current
70515-700	Rilutek	riluzole	Covis Pharma US, Inc	NDA	Current
70515-700	Rilutek	riluzole	Covis Pharma US, Inc	NDA	Current
70515-700	Rilutek	riluzole	Covis Pharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83349	SUPPL	2025-09-12
83342	SUPPL	2025-09-12
83341	SUPPL	2025-09-12
62943	SUPPL	2020-05-13
62918	SUPPL	2020-05-12
57674	ORIG	2019-02-15
34937	SUPPL	2016-04-12
2842	SUPPL	2016-04-11
20756	SUPPL	2016-02-02
20755	SUPPL	2016-02-02
41466	SUPPL	2015-07-20
41465	SUPPL	2015-07-20
41468	SUPPL	2015-03-10
41467	SUPPL	2015-03-10
20757	SUPPL	2015-03-10
25291	SUPPL	2010-01-20
12820	SUPPL	2009-11-17
34936	SUPPL	2009-07-23
12819	SUPPL	2009-07-23
25290	SUPPL	2009-07-17
2841	SUPPL	2009-07-17
2840	SUPPL	2004-09-24
25289	SUPPL	2003-06-08
2839	SUPPL	2003-06-08
2838	SUPPL	2003-06-08