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Oxaliplatin

ANDA 203869, held by Hengrui Pharma. Oxaliplatin.

  • First approved: Jun 18, 2014
  • Supplements approved: 3
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below
DateSubmissionStatusDocuments
Jun 18, 2014Original applicationApprovedNone posted

Products

2 strengths and forms
ProductActive ingredientMarketing
Oxaliplatin50MG/10ML (5MG/ML) · injectable;intravenousOxaliplatinDiscontinued
Oxaliplatin100MG/20ML (5MG/ML) · injectable;intravenousOxaliplatinDiscontinued
All 4 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Jan 5, 2024Supplement 10Labeling · Standard reviewApprovedNone posted
Sep 4, 2020Supplement 6Labeling · Standard reviewApprovedNone posted
Dec 19, 2019Supplement 1Labeling · Standard reviewApprovedNone posted
Jun 18, 2014Original applicationApprovedNone posted

Identifiers

Application
ANDA 203869

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.