Application 216035

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RILUZOLE	RILUZOLE	SUSPENSION;ORAL	50MG/10ML	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
A216035-001	RILUZOLE	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB		2024-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216035-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216035-001	RILUZOLE	50MG/10ML	SUSPENSION / ORAL	AB	2024-08-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216035-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216035-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216035-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216035-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216035-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216035-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216035-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216035-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216035-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216035-001	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216035-001	AB	1	`a50c72e98297…`

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 brand name: Riluzole generic name: RILUZOLE
RILUZOLE	RILUZOLE	Florida Pharmaceutical Products, LLC	ccead445-970c-46a1-9532-2848cc2aa3b6	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: RILUZOLE generic name: RILUZOLE
Riluzole	RILUZOLE	AvKARE	b117b981-476c-f9b8-e053-2995a90aee5f	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: Riluzole 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 brand name: riluzole generic name: RILUZOLE
Riluzole	RILUZOLE	Sun Pharmaceutical Industries, Inc.	4c851be4-f0d0-4b24-baf9-427ddfc6f7b0	2020-05-16	Warnings, Adverse reactions	Name fallback brand name: Riluzole generic name: RILUZOLE