Drug application

ICATIBANT ACETATE (ICATIBANT ACETATE)

Drugs@FDA ANDA 208317 · FRESENIUS KABI USA

Key facts

Drug name ICATIBANT ACETATE
Active ingredients ICATIBANT ACETATE
Application type ANDA
Application number 208317
Company FRESENIUS KABI USA
Dosage forms INJECTABLE, SUBCUTANEOUS
Strength EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Jun 18, 2020

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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