Drug application

GEMFIBROZIL (GEMFIBROZIL)

Drugs@FDA ANDA 078207 · IMPAX PHARMS

Key facts

Drug name GEMFIBROZIL
Active ingredients GEMFIBROZIL
Application type ANDA
Application number 078207
Company IMPAX PHARMS
Dosage forms TABLET, ORAL
Strength 600MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jun 1, 2007

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

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

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