Application 209873

Type: ANDA
Sponsor: STI PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	INJECTABLE;INJECTION	1MG/ML	No	No

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
A209873-001	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP		2019-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209873-001	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 2 · 42 observed 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
2026-08-18 06:07:40	2026-07	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`e64feba35796…`

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
2026-08-18 06:07:40	2026-07	A209873-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209873-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209873-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209873-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209873-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209873-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209873-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209873-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209873-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209873-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209873-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209873-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209873-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209873-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209873-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209873-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209873-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209873-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209873-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209873-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209873-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209873-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209873-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209873-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209873-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209873-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209873-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209873-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209873-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209873-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209873-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209873-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209873-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209873-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209873-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209873-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209873-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209873-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209873-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209873-001	AP	1	`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 2 · 37 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 brand name: Arsenic Trioxide generic name: ARSENIC TRIOXIDE
Trisenox	ARSENIC TRIOXIDE	Cephalon, LLC	101fc347-d0ad-4aee-8b06-9feb187fd741	2025-10-28	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 brand name: Arsenic Trioxide 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 brand name: ARSENIC TRIOXIDE 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 brand name: Arsenic trioxide 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 brand name: Arsenic trioxide 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 brand name: ARSENIC TRIOXIDE 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 brand name: Arsenic Trioxide 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 brand name: Arsenic trioxide 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 brand name: Arsenic trioxide 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 brand name: ARSENIC TRIOXIDE 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 brand name: Arsenic Trioxide 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 brand name: ARSENIC TRIOXIDE 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

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
54879-027	Arsenic Trioxide	Arsenic Trioxide	STI Pharma LLC	ANDA	Current
54879-027	Arsenic Trioxide	Arsenic Trioxide	STI Pharma LLC	ANDA	Current
54879-027	Arsenic Trioxide	Arsenic Trioxide	STI Pharma LLC	ANDA	Current
54879-027	Arsenic Trioxide	Arsenic Trioxide	STI Pharma LLC	ANDA	Current
54879-027	Arsenic Trioxide	Arsenic Trioxide	STI Pharma LLC	ANDA	Current