Drug application

EFAVIRENZ (EFAVIRENZ)

Drugs@FDA ANDA 078886 · HETERO LABS LTD III

Key facts

Drug name EFAVIRENZ
Active ingredients EFAVIRENZ
Application type ANDA
Application number 078886
Company HETERO LABS LTD III
Dosage forms TABLET, ORAL
Strength 600MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Apr 27, 2018

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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