Orange Book product

TESTOSTERONE ENANTHATE 200MG/ML

Orange Book ANDA 212659 · EUGIA PHARMA SPECIALITIES LTD · Prescription

Key facts

Proprietary name TESTOSTERONE ENANTHATE
Active ingredients TESTOSTERONE ENANTHATE
Strength 200MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA212659
Applicant holder EUGIA PHARMA SPECIALITIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AO
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 28, 2024

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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