Orange Book product

FENOFIBRATE 54MG

Orange Book ANDA 207803 · BOSTAL LLC · Prescription

Key facts

Proprietary name FENOFIBRATE
Active ingredients FENOFIBRATE
Strength 54MG
Dosage form TABLET
Route ORAL
Application ANDA207803
Applicant holder BOSTAL LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 19, 2017

At a glance

  • 10–99 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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