Drug application

ABACAVIR SULFATE (ABACAVIR SULFATE)

Drugs@FDA ANDA 078119 · CIPLA

Key facts

Drug name ABACAVIR SULFATE
Active ingredients ABACAVIR SULFATE
Application type ANDA
Application number 078119
Company CIPLA
Dosage forms TABLET, ORAL
Strength EQ 300MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Nov 21, 2017

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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