Orange Book product

TRAZODONE HYDROCHLORIDE 150MG

Orange Book ANDA 218988 · GRANULES INDIA LTD · Prescription

Key facts

Proprietary name TRAZODONE HYDROCHLORIDE
Active ingredients TRAZODONE HYDROCHLORIDE
Strength 150MG
Dosage form TABLET
Route ORAL
Application ANDA218988
Applicant holder GRANULES INDIA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 8, 2024

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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