Application 217413

Type: ANDA
Sponsor: MSN

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
002	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	INJECTABLE;INJECTION	2MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217413-001	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP		2023-04-20
A217413-002	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP		2023-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217413-001	AP
A217413-002	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 2 · 46 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	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217413-001	ARSENIC TRIOXIDE	1MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217413-002	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE / INJECTION	AP	2023-04-20	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 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	A217413-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217413-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217413-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217413-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217413-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217413-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217413-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217413-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217413-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217413-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217413-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217413-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217413-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217413-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217413-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217413-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217413-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217413-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217413-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217413-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217413-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217413-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217413-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217413-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217413-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217413-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217413-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217413-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217413-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217413-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217413-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217413-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217413-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217413-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217413-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217413-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217413-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217413-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217413-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217413-002	AP	1	`9b2671bbb829…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Northstar Rx LLC	48388282-3768-4309-8982-2766cbc9fd59	2024-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217413 application number: ANDA217413
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Novadoz Pharmaceuticals LLC	8849c8f9-ee41-4ccd-8a62-67b04e80a276	2024-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217413 application number: ANDA217413
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Sintetica US LLC	d921f52f-2f38-4300-ae40-31f00b3a500a	2023-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217413 application number: ANDA217413
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	Orbicular Pharmaceutical Technologies Private Limited	3b007d59-99ad-409f-a71e-7f4e7d6f6b12	2023-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217413 application number: ANDA217413