Drug application

LAMIVUDINE, NEVIRAPINE, AND STAVUDINE (LAMIVUDINE, NEVIRAPINE, STAVUDINE)

Drugs@FDA NDA 200244 · HETERO DRUGS LTD

Key facts

Drug name LAMIVUDINE, NEVIRAPINE, AND STAVUDINE
Active ingredients LAMIVUDINE, NEVIRAPINE, STAVUDINE
Application type NDA
Application number 200244
Company HETERO DRUGS LTD
Dosage forms TABLET, ORAL
Strength 150MG; 200MG; 30MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Sep 10, 2010

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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