Drug application

MICAFUNGIN (MICAFUNGIN SODIUM)

Drugs@FDA NDA 212125 · TEVA PHARMS USA INC

Key facts

Drug name MICAFUNGIN
Active ingredients MICAFUNGIN SODIUM
Application type NDA
Application number 212125
Company TEVA PHARMS USA INC
Dosage forms POWDER, INTRAVENOUS
Strength EQ 50MG BASE/VIAL
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Jul 30, 2021

At a glance

  • 1–9 Submissions
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

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 · Source date:

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