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Fosaprepitant Dimeglumine

ANDA 206197, held by Fresenius Kabi USA. Fosaprepitant Dimeglumine.

  • First approved: Jun 9, 2016
  • Review: Standard
  • Supplements approved: 4
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below
DateSubmissionStatusDocuments
Jun 9, 2016Original applicationApprovedLabelLetter

Products

1 strengths and forms
ProductActive ingredientMarketing
Fosaprepitant DimeglumineEQ 150MG BASE/VIAL · powder;intravenousFosaprepitant DimeglumineRx
All 5 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Aug 7, 2026Supplement 9Labeling · Standard reviewApprovedNone posted
Aug 29, 2023Supplement 8Labeling · Standard reviewApprovedNone posted
Jan 6, 2021Supplement 1Labeling · Standard reviewApprovedNone posted
Jan 6, 2021Supplement 4Labeling · Standard reviewApprovedNone posted
Jun 9, 2016Original applicationApprovedLabelLetter

Identifiers

Application
ANDA 206197

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.