Orange Book product

TRENTAL 400MG

Orange Book NDA 018631 · VALIDUS PHARMACEUTICALS LLC · Prescription

Key facts

Proprietary name TRENTAL
Active ingredients PENTOXIFYLLINE
Strength 400MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application NDA018631
Applicant holder VALIDUS PHARMACEUTICALS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Aug 30, 1984

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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