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Icatibant Acetate

ANDA 208317, held by Fresenius Kabi USA. Icatibant Acetate.

  • First approved: Jun 18, 2020
  • 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
Jun 18, 2020Original applicationApprovedNone posted

Products

1 strengths and forms
ProductActive ingredientMarketing
Icatibant AcetateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · injectable;subcutaneousIcatibant AcetateRx
All 3 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Oct 23, 2026Supplement 7ManufacturingApprovedNone posted
May 9, 2025Supplement 3Labeling · Standard reviewApprovedNone posted
Jun 18, 2020Original applicationApprovedNone posted

Identifiers

Application
ANDA 208317

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.