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Arsenic Trioxide

ANDA 208231, held by Fresenius Kabi USA. Arsenic Trioxide.

  • First approved: Aug 31, 2018
  • Review: Standard
  • Supplements approved: 2
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below
DateSubmissionStatusDocuments
Aug 31, 2018Original applicationApprovedLetter

Products

1 strengths and forms
ProductActive ingredientMarketing
Arsenic Trioxide1MG/ML · injectable;injectionArsenic TrioxideRx
All 3 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Oct 11, 2023Supplement 2Labeling · Standard reviewApprovedNone posted
Oct 11, 2023Supplement 3Labeling · Standard reviewApprovedNone posted
Aug 31, 2018Original applicationApprovedLetter

Identifiers

Application
ANDA 208231

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.