Orange Book product

TESTOSTERONE 50MG/5GM PACKET

Orange Book ANDA 076744 · STRIDES PHARMA INTERNATIONAL AG · Prescription

Key facts

Proprietary name TESTOSTERONE
Active ingredients TESTOSTERONE
Strength 50MG/5GM PACKET
Dosage form GEL
Route TRANSDERMAL
Application ANDA076744
Applicant holder STRIDES PHARMA INTERNATIONAL AG
Marketing status Prescription
Therapeutic equivalence (TE) code AB1
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 23, 2007

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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