Orange Book product

FENOFIBRATE (MICRONIZED) 200MG

Orange Book ANDA 212232 · AUROBINDO PHARMA LTD · Prescription

Key facts

Proprietary name FENOFIBRATE (MICRONIZED)
Active ingredients FENOFIBRATE
Strength 200MG
Dosage form CAPSULE
Route ORAL
Application ANDA212232
Applicant holder AUROBINDO PHARMA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 20, 2021

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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