Orange Book product

TESTOSTERONE CYPIONATE 200MG/ML

Orange Book ANDA 040530 · PADAGIS US LLC · Prescription

Key facts

Proprietary name TESTOSTERONE CYPIONATE
Active ingredients TESTOSTERONE CYPIONATE
Strength 200MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA040530
Applicant holder PADAGIS US LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AO
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 31, 2005

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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