FDA.reportPublic FDA data

Application 078729

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARSENIC TRIOXIDEARSENIC TRIOXIDEINJECTABLE; INJECTION10MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arsenic TrioxideARSENIC TRIOXIDEHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc8dddfe9e-06bf-4983-9c55-71b19da8fcdc2025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Arsenic Trioxide
generic name: ARSENIC TRIOXIDE
Arsenic TrioxideARSENIC TRIOXIDEFresenius Kabi USA, LLCa482eccd-8837-47ea-904d-2f2c294d10fa2025-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Arsenic Trioxide
generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDEARSENIC TRIOXIDEEugia US LLC2a999752-f350-4eff-97e7-e7106dfa85b52025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ARSENIC TRIOXIDE
generic name: ARSENIC TRIOXIDE
Arsenic trioxideARSENIC TRIOXIDEZydus Pharmaceuticals USA Inc.3e1d2b63-ccb2-4e97-a009-5983eabf65e42025-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Arsenic trioxide
generic name: ARSENIC TRIOXIDE
Arsenic trioxideARSENIC TRIOXIDEZydus Pharmaceuticals USA Inc.ae5cae02-ca57-4da5-8940-81253fdb86792025-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Arsenic trioxide
generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDEARSENIC TRIOXIDENordic Pharma, Inc.d1e2107c-26c3-40fc-978e-0ba5b84098ac2025-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ARSENIC TRIOXIDE
generic name: ARSENIC TRIOXIDE
Arsenic TrioxideARSENIC TRIOXIDENexus Pharmaceuticals LLC2b2a7ed9-5ed3-42fc-b19b-d507003962332025-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Arsenic Trioxide
generic name: ARSENIC TRIOXIDE
Arsenic trioxideARSENIC TRIOXIDEZydus Pharmaceuticals USA Inc.e9d27f88-de82-4379-b143-4b94b3dd8bbe2025-02-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Arsenic trioxide
generic name: ARSENIC TRIOXIDE
Arsenic trioxideARSENIC TRIOXIDEZydus Pharmaceuticals USA Inc.e1ad5d87-e65e-402f-86b5-e641fc4e61ab2025-02-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Arsenic trioxide
generic name: ARSENIC TRIOXIDE
Arsenicum Album 200ckARSENIC TRIOXIDESEVENE USAc8d6dcbf-a5a9-5231-e053-2a95a90a73542025-02-11WarningsName fallback
generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDEARSENIC TRIOXIDENorthstar Rx LLC48388282-3768-4309-8982-2766cbc9fd592024-10-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ARSENIC TRIOXIDE
generic name: ARSENIC TRIOXIDE
Arsenic TrioxideARSENIC TRIOXIDEGland Pharma Limited2cb52683-1e74-4831-a771-55a78536cfe52024-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Arsenic Trioxide
generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDEARSENIC TRIOXIDENovadoz Pharmaceuticals LLC8849c8f9-ee41-4ccd-8a62-67b04e80a2762024-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ARSENIC TRIOXIDE
generic name: ARSENIC TRIOXIDE
Arsenicum Album 30cARSENIC TRIOXIDESEVENE USA97e7b573-bdc0-4b04-bf24-a24a037cdd192024-01-23WarningsName fallback
generic name: ARSENIC TRIOXIDE
Arsenicum albumARSENIC TRIOXIDEBoiron84239859-3fc6-24da-e053-2a91aa0a34202023-12-21Name fallback
generic name: ARSENIC TRIOXIDE
Arsenicum albumARSENIC TRIOXIDEBoiron84effad6-a09f-7420-e053-2a91aa0aa55e2023-12-21Name fallback
generic name: ARSENIC TRIOXIDE
Arsenicum albumARSENIC TRIOXIDEBoiron8423631c-cc03-91a1-e053-2991aa0ac3892023-12-21Name fallback
generic name: ARSENIC TRIOXIDE
Arsenicum albumARSENIC TRIOXIDEBoironaf651430-79fe-11e6-8a76-424c583030312023-12-21Name fallback
generic name: ARSENIC TRIOXIDE
Arsenicum albumARSENIC TRIOXIDEBoiron84235a97-161a-175f-e053-2991aa0a16cd2023-12-21Name fallback
generic name: ARSENIC TRIOXIDE
ARSENIC TRIOXIDEARSENIC TRIOXIDESintetica US LLCd921f52f-2f38-4300-ae40-31f00b3a500a2023-11-15Boxed warning, Warnings, Adverse reactionsName 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.