Orange Book product

GEMFIBROZIL 600MG

Orange Book ANDA 074442 · WATSON LABORATORIES INC · Discontinued

Key facts

Proprietary name GEMFIBROZIL
Active ingredients GEMFIBROZIL
Strength 600MG
Dosage form TABLET
Route ORAL
Application ANDA074442
Applicant holder WATSON LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 28, 1995

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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