Drug application

LAMIVUDINE (LAMIVUDINE)

Drugs@FDA ANDA 090433 · ALKEM LABS LTD

Key facts

Drug name LAMIVUDINE
Active ingredients LAMIVUDINE
Application type ANDA
Application number 090433
Company ALKEM LABS LTD
Dosage forms TABLET, ORAL
Strength 150MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Mar 16, 2009

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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