Drug application

IMPAVIDO (MILTEFOSINE)

Drugs@FDA NDA 204684 · KNIGHT THERAPS

Key facts

Drug name IMPAVIDO
Active ingredients MILTEFOSINE
Application type NDA
Application number 204684
Company KNIGHT THERAPS
Dosage forms CAPSULE, ORAL
Strength 50MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Mar 19, 2014

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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