Home Applications 021248 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ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 TRISENOX ARSENIC TRIOXIDE INJECTABLE;INJECTION 2MG/ML Yes Yes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date N021248-001 TRISENOX ARSENIC TRIOXIDE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 N021248-002 TRISENOX ARSENIC TRIOXIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS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N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021248-002 TRISENOX 2MG/ML INJECTABLE /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N021248-001 TRISENOX 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2000-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021248-002 TRISENOX 2MG/ML INJECTABLE /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.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 78 observed states.
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 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 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 generic name: ARSENIC TRIOXIDE Arsenic trioxide ARSENIC TRIOXIDE Zydus Lifesciences Limited 25e8295c-b5d9-4322-a093-d907ab1d1d35 2022-11-05 Name fallback generic name: ARSENIC TRIOXIDE Arsenic trioxide ARSENIC TRIOXIDE Zydus Lifesciences Limited 2ad7bb19-6152-4158-a179-2388e86a981f 2022-11-05 Name fallback 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 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 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