Application 021248

Type: NDA
Sponsor: CEPHALON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRISENOX	ARSENIC TRIOXIDE	INJECTABLE;INJECTION	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	TRISENOX	ARSENIC TRIOXIDE	INJECTABLE;INJECTION	2MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021248-001	TRISENOX	ARSENIC TRIOXIDE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25
N021248-002	TRISENOX	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021248-002	AP

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021248-001	TRISENOX	1MG/ML	INJECTABLE / INJECTION		RLD	2000-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021248-001	TRISENOX	1MG/ML	INJECTABLE / INJECTION		RLD	2000-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021248-001	TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD	2000-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021248-002	TRISENOX	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-10-13	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021248-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021248-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021248-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021248-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021248-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021248-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021248-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021248-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021248-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021248-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021248-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021248-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021248-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021248-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021248-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021248-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021248-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021248-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021248-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021248-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021248-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021248-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021248-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021248-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021248-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021248-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021248-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021248-002	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021248-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021248-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021248-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021248-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021248-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021248-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021248-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021248-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021248-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021248-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021248-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021248-002	AP	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021248-001	ODE-167	2025-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021248-002	ODE-167	2025-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021248-001	ODE-167	2025-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021248-002	ODE-167	2025-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021248-001	ODE-167	2025-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021248-002	ODE-167	2025-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021248-001	ODE-167	2025-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021248-002	ODE-167	2025-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021248-001	ODE-167	2025-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021248-002	ODE-167	2025-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021248-001	ODE-167	2025-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021248-002	ODE-167	2025-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021248-001	ODE-167	2025-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021248-002	ODE-167	2025-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021248-001	ODE-167	2025-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021248-002	ODE-167	2025-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021248-001	ODE-167	2025-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021248-002	ODE-167	2025-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021248-001	ODE-167	2025-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021248-002	ODE-167	2025-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021248-001	ODE-167	2025-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021248-002	ODE-167	2025-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021248-001	ODE-167	2025-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021248-002	ODE-167	2025-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021248-001	ODE-167	2025-01-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021248-002	ODE-167	2025-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021248-001	ODE-167	2025-01-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021248-002	ODE-167	2025-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021248-001	ODE-167	2025-01-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021248-002	ODE-167	2025-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021248-001	ODE-167	2025-01-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021248-002	ODE-167	2025-01-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021248-001	ODE-167	2025-01-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021248-002	ODE-167	2025-01-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021248-001	ODE-167	2025-01-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021248-002	ODE-167	2025-01-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021248-001	ODE-167	2025-01-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021248-002	ODE-167	2025-01-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021248-001	ODE-167	2025-01-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021248-002	ODE-167	2025-01-12	`87673890dc5c…`

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arsenic Trioxide	ARSENIC TRIOXIDE	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc	8dddfe9e-06bf-4983-9c55-71b19da8fcdc	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
Arsenic Trioxide	ARSENIC TRIOXIDE	Fresenius Kabi USA, LLC	a482eccd-8837-47ea-904d-2f2c294d10fa	2025-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Eugia US LLC	2a999752-f350-4eff-97e7-e7106dfa85b5	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Pharmaceuticals USA Inc.	3e1d2b63-ccb2-4e97-a009-5983eabf65e4	2025-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Pharmaceuticals USA Inc.	ae5cae02-ca57-4da5-8940-81253fdb8679	2025-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Nordic Pharma, Inc.	d1e2107c-26c3-40fc-978e-0ba5b84098ac	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
Arsenic Trioxide	ARSENIC TRIOXIDE	Nexus Pharmaceuticals LLC	2b2a7ed9-5ed3-42fc-b19b-d50700396233	2025-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Pharmaceuticals USA Inc.	e9d27f88-de82-4379-b143-4b94b3dd8bbe	2025-02-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Pharmaceuticals USA Inc.	e1ad5d87-e65e-402f-86b5-e641fc4e61ab	2025-02-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum Album 200ck	ARSENIC TRIOXIDE	SEVENE USA	c8d6dcbf-a5a9-5231-e053-2a95a90a7354	2025-02-11	Warnings	Name fallback generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Northstar Rx LLC	48388282-3768-4309-8982-2766cbc9fd59	2024-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
Arsenic Trioxide	ARSENIC TRIOXIDE	Gland Pharma Limited	2cb52683-1e74-4831-a771-55a78536cfe5	2024-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Novadoz Pharmaceuticals LLC	8849c8f9-ee41-4ccd-8a62-67b04e80a276	2024-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum Album 30c	ARSENIC TRIOXIDE	SEVENE USA	97e7b573-bdc0-4b04-bf24-a24a037cdd19	2024-01-23	Warnings	Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	84239859-3fc6-24da-e053-2a91aa0a3420	2023-12-21		Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	84effad6-a09f-7420-e053-2a91aa0aa55e	2023-12-21		Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	8423631c-cc03-91a1-e053-2991aa0ac389	2023-12-21		Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	af651430-79fe-11e6-8a76-424c58303031	2023-12-21		Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	84235a97-161a-175f-e053-2991aa0a16cd	2023-12-21		Name fallback generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Sintetica US LLC	d921f52f-2f38-4300-ae40-31f00b3a500a	2023-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARSENIC TRIOXIDE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63459-600	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-600	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-600	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-601	Trisenox	Arsenic Trioxide	Cephalon, LLC	NDA	Current
63459-601	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-601	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-601	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-601	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-601	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-601	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-601	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current
63459-601	Trisenox	Arsenic Trioxide	Cephalon, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64959	SUPPL	2020-10-21
64951	SUPPL	2020-10-21
59154	SUPPL	2019-06-21
59147	SUPPL	2019-06-21
51070	SUPPL	2018-01-17
51058	SUPPL	2018-01-17
4756	SUPPL	2015-02-24
14729	SUPPL	2015-02-23
36449	SUPPL	2010-07-30
14728	SUPPL	2010-07-30
27197	SUPPL	2010-07-28
4755	SUPPL	2010-07-28
42052	ORIG	2001-07-12
27196	ORIG	2000-09-25
14727	ORIG	2000-09-25