Drug application

EFAVIRENZ (EFAVIRENZ)

Drugs@FDA ANDA 078958 · EMCURE PHARMA

Key facts

Drug name EFAVIRENZ
Active ingredients EFAVIRENZ
Application type ANDA
Application number 078958
Company EMCURE PHARMA
Dosage forms TABLET, ORAL
Strength 600MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Dec 20, 2007

At a glance

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