Drug application

ABACAVIR SULFATE (ABACAVIR SULFATE)

Drugs@FDA NDA 200733 · MATRIX LABS LTD

Key facts

Drug name ABACAVIR SULFATE
Active ingredients ABACAVIR SULFATE
Application type NDA
Application number 200733
Company MATRIX LABS LTD
Dosage forms TABLET, ORAL
Strength 60 MG
Marketing status None (Tentative Approval)
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Nov 29, 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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