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 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A209873-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2019-05-06	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A209873-001	AP	1	`84e616aacf4f…`
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…`

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arsenicum album	ARSENIC TRIOXIDE	Boiron	84ef1179-8c0d-5942-e053-2a91aa0af3aa	2023-08-29		Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	8423ddee-c453-1634-e053-2a91aa0a7cb8	2023-07-26		Name fallback generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Orbicular Pharmaceutical Technologies Private Limited	3b007d59-99ad-409f-a71e-7f4e7d6f6b12	2023-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ARSENIC TRIOXIDE generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	84231e29-485b-fc6b-e053-2991aa0a83c3	2023-04-11		Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	84efbbc2-6396-eb15-e053-2a91aa0ac8dd	2023-04-11		Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	84232d7c-a244-89de-e053-2a91aa0a1de6	2023-04-11		Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	84f011b9-d5f0-dc0b-e053-2a91aa0a2aef	2023-03-03		Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum album	ARSENIC TRIOXIDE	Boiron	84efbbc2-63a0-eb15-e053-2a91aa0ac8dd	2023-02-20		Name fallback generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Ingenus Pharmaceuticals, LLC	c99b01b4-67ff-4793-8375-fe3a21c6c9be	2023-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ARSENIC TRIOXIDE generic name: ARSENIC TRIOXIDE
Arsenic Trioxide	ARSENIC TRIOXIDE	Sagent Pharmaceuticals	7fe0fe9f-e87b-44ab-b92c-9b3d23942063	2022-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Arsenic Trioxide generic name: ARSENIC TRIOXIDE
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Lifesciences Limited	25e8295c-b5d9-4322-a093-d907ab1d1d35	2022-11-05		Name fallback brand name: Arsenic trioxide generic name: ARSENIC TRIOXIDE
Arsenic trioxide	ARSENIC TRIOXIDE	Zydus Lifesciences Limited	2ad7bb19-6152-4158-a179-2388e86a981f	2022-11-05		Name fallback brand name: Arsenic trioxide generic name: ARSENIC TRIOXIDE
Arsenic Trioxide	ARSENIC TRIOXIDE	Sandoz Inc	a9008658-c2dd-49f4-b1c4-26e232c81957	2022-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Arsenic Trioxide generic name: ARSENIC TRIOXIDE
Arsenicum Album 200C	ARSENIC TRIOXIDE	Natural Creations, Inc.	e08c2531-cb00-4016-a2a8-f6c88f0e306c	2022-02-17	Warnings	Name fallback generic name: ARSENIC TRIOXIDE
Arsenicum Album 30C	ARSENIC TRIOXIDE	Natural Creations, Inc.	37797a8f-38b9-4007-9d2c-62df4dc92d8a	2022-02-17	Warnings	Name fallback generic name: ARSENIC TRIOXIDE
Arsenic Trioxide	ARSENIC TRIOXIDE	Amneal Pharmaceuticals LLC	5845022e-8c01-451b-ae49-a28e58c5f845	2021-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Arsenic Trioxide 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 · 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