Drug application

SORAFENIB TOSYLATE (SORAFENIB TOSYLATE)

Drugs@FDA ANDA 207012 · MYLAN

Key facts

Drug name SORAFENIB TOSYLATE
Active ingredients SORAFENIB TOSYLATE
Application type ANDA
Application number 207012
Company MYLAN
Dosage forms TABLET, ORAL
Strength EQ 200MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Sep 10, 2020

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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