Orange Book product

TENOFOVIR DISOPROXIL FUMARATE 250MG

Orange Book ANDA 090647 · AUROBINDO PHARMA LTD · Prescription

Key facts

Proprietary name TENOFOVIR DISOPROXIL FUMARATE
Active ingredients TENOFOVIR DISOPROXIL FUMARATE
Strength 250MG
Dosage form TABLET
Route ORAL
Application ANDA090647
Applicant holder AUROBINDO PHARMA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 26, 2018

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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