Drug application

MYCOPHENOLATE MOFETIL HYDROCHLORIDE (MYCOPHENOLATE MOFETIL HYDROCHLORIDE)

Drugs@FDA ANDA 203859 · MYLAN LABS LTD

Key facts

Drug name MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Active ingredients MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Application type ANDA
Application number 203859
Company MYLAN LABS LTD
Dosage forms INJECTABLE, INJECTION
Strength 500MG/VIAL
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Mar 31, 2017

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 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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