Orange Book product

PENTOXIFYLLINE 400MG

Orange Book ANDA 075191 · APOTEX INC · Prescription

Key facts

Proprietary name PENTOXIFYLLINE
Active ingredients PENTOXIFYLLINE
Strength 400MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA075191
Applicant holder APOTEX INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jun 9, 1999

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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