Orange Book product

DEPO-TESTOSTERONE 100MG/ML

Orange Book ANDA 085635 · PFIZER INC · Prescription

Key facts

Proprietary name DEPO-TESTOSTERONE
Active ingredients TESTOSTERONE CYPIONATE
Strength 100MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA085635
Applicant holder PFIZER INC
Marketing status Prescription
Therapeutic equivalence (TE) code AO
Reference listed drug (RLD) Yes
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
  • Yes 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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