Home Applications 078729 Application 078729
Type ANDA
Sponsor TEVA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE; INJECTION 10ML No No
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 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.