Orange Book product

TRAZODONE HYDROCHLORIDE 25MG

Orange Book ANDA 072193 · OXFORD PHARMACEUTICALS LLC · Prescription

Key facts

Proprietary name TRAZODONE HYDROCHLORIDE
Active ingredients TRAZODONE HYDROCHLORIDE
Strength 25MG
Dosage form TABLET
Route ORAL
Application ANDA072193
Applicant holder OXFORD PHARMACEUTICALS LLC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Sep 1, 2026

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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