Orange Book product

TESTOPEL 75MG

Orange Book ANDA 080911 · ENDO OPERATIONS LTD · Prescription

Key facts

Proprietary name TESTOPEL
Active ingredients TESTOSTERONE
Strength 75MG
Dosage form PELLET
Route IMPLANTATION
Application ANDA080911
Applicant holder ENDO OPERATIONS LTD
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jan 1, 1982

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)

Browse all Orange Book products